80 Subpart I—Multipurpose Additives

§ 172.800 21 CFR Ch. I (4–1–11 Edition)

Subpart I—Multipurpose Additives uses, it shall be labeled in compliance with part 105 of this chapter. § 172.800 Acesulfame potassium. [53 FR 28382, July 28, 1988, as amended at 57 Acesulfame potassium (CAS Reg. No. FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, 55589–62–3), also known as acesulfame Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003] K, may be safely used as a general-purpose sweetener and flavor enhancer in § 172.802 Acetone peroxides. foods generally, except in meat and The food additive acetone peroxides poultry, in accordance with current may be safely used in flour, and in good manufacturing practice and in an bread and rolls where standards of amount not to exceed that reasonably identity do not preclude its use, in ac- required to accomplish the intended cordance with the following prescribed technical effect in foods for which conditions: standards of identity established under (a) The additive is a mixture of section 401 of the Federal Food, Drug, monomeric and linear dimeric acetone and Cosmetic Act do not preclude such peroxide, with minor proportions of use, under the following conditions: higher polymers, manufactured by re- (a) Acesulfame potassium is the po- action of hydrogen peroxide and ace- tassium salt of 6-methyl-1,2,3- tone. oxathiazine-4(3H)-one-2,2-dioxide. (b) The additive may be mixed with (b) The additive meets the following an edible carrier to give a concentra- specifications: tion of: (1) 3 grams to 10 grams of hy- (1) Purity is not less than 99 percent drogen peroxide equivalent per 100 on a dry basis. The purity shall be de- grams of the additive, plus carrier, for termined by a method titled use in flour maturing and bleaching; or ‘‘Acesulfame Potassium Assay,’’ which (2) approximately 0.75 gram of hydro- is incorporated by reference. Copies are gen peroxide equivalent per 100 grams available from the Center for Food of the additive, plus carrier, for use in Safety and Applied Nutrition (HFS– dough conditioning. 200), Food and Drug Administration, (c) It is used or intended for use: (1) 5100 Paint Branch Pkwy., College Park, In maturing and bleaching of flour in a MD 20740, or available for inspection at quantity not more than sufficient for the National Archives and Records Ad- such effect; and (2) as a dough-condi- ministration (NARA). For information tioning agent in bread and roll produc- on the availability of this material at tion at not to exceed the quantity of NARA, call 202–741–6030, or go to: http:// hydrogen peroxide equivalent necessary for the artificial maturing ef- www.archives.gov/federallregister/ fect. codeloflfederallregulations/ (d) To insure safe use of the additive, ibrllocations.html. the label of the food additive container (2) Fluoride content is not more than and any intermediate premix thereof 30 parts per million, as determined by shall bear, in addition to the other in- method III of the Fluoride Limit Test formation required by the act: of the Food Chemicals Codex, 3d Ed. (1) The name of the additive, ‘‘ace- (1981), p. 511, which is incorporated by tone peroxides’’. reference. Copies are available from (2) The concentration of the additive the National Academy Press, 2101 Con- expressed in hydrogen peroxide equiva- stitution Ave. NW., Washington, DC lents per 100 grams. 20418, or available for inspection at the (3) Adequate use directions to provide National Archives and Records Admin- a final product that complies with the istration (NARA). For information on limitations prescribed in paragraph (c) the availability of this material at of this section. NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 172.804 Aspartame. codeloflfederallregulations/ The food additive aspartame may be ibrllocations.html. safely used in food in accordance with (c) If the food containing the additive good manufacturing practice as a is represented to be for special dietary sweetening agent and a flavor enhancer

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00090 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.804

in foods for which standards of identity and Drug Administration, 5100 Paint established under section 401 of the act Branch Pkwy., College Park, MD 20740, do not preclude such use under the fol- and at the National Archives and lowing conditions: Records Administration (NARA). For (a) Aspartame is the chemical 1- information on the availability of this methyl N-L-a-aspartyl-L-phenylalanine material at NARA, call 202–741–6030, or (C14H18N2O5). go to: http://www.archives.gov/ (b) The additive meets the specifica- federallregister/ tions of the ‘‘Food Chemicals Codex,’’ codeloflfederallregulations/ 3d Ed. (1981) pp. 28–29 and First Supple- ibrllocations.html. ment p. 5, which is incorporated by ref- (d) To assure safe use of the additive, erence in accordance with 5 U.S.C. in addition to the other information re- 552(a). Copies are available from the National Academy Press, 2101 Constitu- quired by the Act: tion Ave. NW., Washington, DC 20418, (1) The principal display panel of any or may be examined at the Center for intermediate mix of the additive for Food Safety and Applied Nutrition’s manufacturing purposes shall bear a Library, Food And Drug Administra- statement of the concentration of the tion, 5100 Paint Branch Pkwy., College additive contained therein; Park, MD 20740, or at the National Ar- (2) The label of any food containing chives and Records Administration the additive shall bear, either on the (NARA). For information on the avail- principal display panel or on the infor- ability of this material at NARA, call mation panel, the following statement: 202–741–6030, or go to: http:// www.archives.gov/federallregister/ PHENYLKETONURICS: CONTAINS codeloflfederallregulations/ PHENYLALANINE ibrllocations.html. (c)(1) When aspartame is used as a The statement shall appear in the la- sugar substitute tablet for sweetening beling prominently and conspicuously hot beverages, including coffee and tea, as compared to other words, state- L-leucine may be used as a lubricant in ments, designs or devices and in bold the manufacture of such tablets at a type and on clear contrasting back- level not to exceed 3.5 percent of the ground in order to render it likely to weight of the tablet. be read and understood by the ordinary (2) When aspartame is used in baked individual under customary conditions goods and baking mixes, the amount of of purchase and use. the additive is not to exceed 0.5 percent (3) When the additive is used in a by weight of ready-to-bake products or sugar substitute for table use, its label of finished formulations prior to bak- shall bear instructions not to use in ing. Generally recognized as safe cooking or baking. (GRAS) ingredients or food additives (4) Packages of the dry, free-flowing approved for use in baked goods shall additive shall prominently display the be used in combination with aspartame sweetening equivalence in teaspoons of to ensure its functionality as a sweet- sugar. ener in the final baked product. The (e) If the food containing the additive level of aspartame used in these prod- purports to be or is represented for spe- ucts is determined by an analytical method entitled ‘‘Analytical Method cial dietary uses, it shall be labeled in for the Determination of Aspartame compliance with part 105 of this chap- and Diketopiperazine in Baked Goods ter. and Baking Mixes,’’ October 8, 1992, [39 FR 27319, July 26, 1974] which was developed by the Nutrasweet Co. Copies are available from the Office EDITORIAL NOTE: For FEDERAL REGISTER ci- of Premarket Approval (HFS–200), Cen- tations affecting § 172.804, see the List of CFR Sections Affected, which appears in the ter for Food Safety and Applied Nutri- Finding Aids section of the printed volume tion, 5100 Paint Branch Pkwy., College and at www.fdsys.gov. Park, MD 20740, or are available for inspection at the Center for Food Safety and Applied Nutrition’s Library, Food

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00091 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.806 21 CFR Ch. I (4–1–11 Edition)

§ 172.806 Azodicarbonamide. minimum cloud point of 9 °C–12 °C in 10 percent aqueous solution. The food additive azodicarbonamide (4) a-Hydro-omega-hydroxy-poly(ox- may be safely used in food in accord- yethylene) poly (oxypropylene)-(51–57 ance with the following prescribed con- moles) poly(oxyethylene) block copoly- ditions: mer, having an average molecular (a) It is used or intended for use: weight of 14,000 and a cloud point above (1) As an aging and bleaching ingre- 100 °C in 1 percent aqueous solution. dient in cereal flour in an amount not (b) The additive is used or intended to exceed 2.05 grams per 100 pounds of for use as follows: flour (0.0045 percent; 45 parts per mil- (1) The additive identified in para- lion). graph (a)(1) of this section is used in (2) As a dough conditioner in bread practice as a solubilizing and stabi- baking in a total amount not to exceed lizing agent in flavor concentrates 0.0045 percent (45 parts per million) by (containing authorized flavoring oils) weight of the flour used, including any for use in foods for which standards of quantity of azodicarbonamide added to identity established under section 401 flour in accordance with paragraph of the Act do not preclude such use, (a)(1) of this section. provided that the weight of the addi- (b) To assure safe use of the additive: tive does not exceed the weight of the (1) The label and labeling of the addi- flavoring oils in the flavor concentrate. tive and any intermediate premix pre- (2) The additive identified in para- pared therefrom shall bear, in addition graph (a)(2) of this section is used as a to the other information required by processing aid and wetting agent in the Act, the following: combination with dioctyl sodium sulfo- (i) The name of the additive. succinate for fumaric acid as pre- (ii) A statement of the concentration scribed in § 172.810. or the strength of the additive in any (3) The additive identified in para- intermediate premixes. graph (a)(3) of this section is used: (2) The label or labeling of the food (i) As a surfactant and defoaming additive shall also bear adequate direc- agent, at levels not to exceed 0.05 per- tions for use. cent by weight, in scald baths for poultry defeathering, followed by potable § 172.808 Copolymer condensates of water rinse. The temperatures of the ethylene oxide and propylene oxide. scald baths shall be not less than 125 Copolymer condensates of ethylene °F. oxide and propylene oxide may be safe- (ii) As a foam control and rinse adju- ly used in food under the following pre- vant in hog dehairing machines at a scribed conditions: use level of not more than 5 grams per (a) The additive consists of one of the hog. following: (4) The additive identified in para- (1) a-Hydro-omega-hydroxy-poly (oxy- graph (a)(4) of this section is used as a ethylene) poly(oxypropylene)-(55–61 dough conditioner in yeast-leavened moles)poly(oxyethylene) block copoly- bakery products for which standards of mer, having a molecular weight range identity established under section 401 of 9,760–13,200 and a cloud point above of the Act do not preclude such use, 100 °C in 1 percent aqueous solution. provided that the amount of the addi- (2) a-Hydro-omega-hydroxy-poly (oxy- tive dose not exceed 0.5 percent by ethylene)poly(oxypropylene)-(53–59 weight of the flour used. moles)poly(oxyethylene)(14–16 moles) [42 FR 14491, Mar. 15, 1977, as amended at 46 block copolymer, having a molecular FR 57476, Nov. 24, 1981] weight range of 3,500–4,125 and a cloud point of 9 °C–12 °C in 10 percent aqueous § 172.809 Curdlan. solution. Curdlan may be safely used in ac- (3) a-Hydro-omega-hydroxy-poly(ox- cordance with the following conditions: yethylene)/poly(oxypropylene) (min- (a) Curdlan is a high molecular imum 15 moles)/poly(oxyethylene) weight polymer of glucose (b-1,3- block copolymer, having a minimum glucan; CAS Reg. No. 54724–00–4) pro- average molecular weight of 1900 and a duced by pure culture fermentation

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00092 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.810

from the nonpathogenic and section 401 of the act do not preclude nontoxicogenic bacterium Alcaligenes such use. faecalis var. myxogenes. [61 FR 65941, Dec. 16, 1996] (b) Curdlan meets the following specifications when it is tested according § 172.810 Dioctyl sodium sulfosuc- to the methods described or referenced cinate. in the document entitled ‘‘Analytical The food additive dioctyl sodium Methods for Specification Tests for sulfosuccinate, which meets the speci- Curdlan,’’ by Takeda Chemical Indus- fications of the Food Chemicals Codex, tries, Ltd., 12–10 Nihonbashi, 2–Chome, 3d Ed. (1981), pp. 102–104, which is incor- Chuo-ku, Tokyo, 103, Japan, 1996, which porated by reference (Copies may be is incorporated by reference in accord- obtained from the National Academy ance with 5 U.S.C. 552(a) and 1 CFR Press, 2101 Constitution Ave. NW., part 51. Copies are available from the Washington, DC 20418, or may be exam- Division of Petition Control (HFS–215), ined at the National Archives and Center for Food Safety and Applied Nu- Records Administration (NARA). For trition, Food and Drug Administration, information on the availability of this 5100 Paint Branch Pkwy., College Park, material at NARA, call 202–741–6030, or MD 20740, or may be examined at the go to: http://www.archives.gov/ Center for Food Safety and Applied Nu- federallregister/ trition’s Library, Food and Drug Ad- codeloflfederallregulations/ ministration, 5100 Paint Branch Pkwy., ibrllocations.html.), may be safely used College Park, MD 20740, or at the Na- in food in accordance with the fol- tional Archives and Records Adminis- lowing prescribed conditions: tration (NARA). For information on (a) As a wetting agent in the fol- the availability of this material at lowing fumaric acid-acidulated foods: NARA, call 202–741–6030, or go to: http:// Dry gelatin dessert, dry beverage base, www.archives.gov/federallregister/ and fruit juice drinks, when standards codeloflfederallregulations/ of identity do not preclude such use. ibrllocations.html. The labeling of the dry gelatin dessert (1) Positive for curdlan. and dry beverage base shall bear ade- (2) Assay for curdlan (calculated as quate directions for use, and the addi- anhydrous glucose), not less than 80 tive shall be used in such an amount percent. that the finished gelatin dessert will (3) pH of 1 percent aqueous suspen- contain not in excess of 15 parts per sion, 6.0–7.5. million of the additive and the finished (4) Lead, not more than 0.5 mg/kg. beverage or fruit juice drink will con- (5) Heavy metals (as Pb), not more tain not in excess of 10 parts per mil- than 0.002 percent. lion of the additive. (b) As a processing aid in sugar fac- (6) Total nitrogen, not more than 0.2 tories in the production of unrefined percent. cane sugar, in an amount not in excess (7) Loss on drying, not more than 10 of 0.5 part per million of the additive percent. per percentage point of sucrose in the (8) Residue on ignition, not more juice, syrup, or massecuite being proc- than 6 percent. essed, and so used that the final molas- (9) Gel strength of 2 percent aqueous ses will contain no more than 25 parts suspension, not less than 600×103 dyne per million of the additive. per square centimeter. (c) As a solubilizing agent on gums (10) Aerobic plate count, not more and hydrophilic colloids to be used in than 103 per gram. food as stabilizing and thickening (11) Coliform bacteria, not more than agents, when standards of identity do 3 per gram. not preclude such use. The additive is (c) Curdlan is used or intended for used in an amount not to exceed 0.5 use in accordance with good manufac- percent by weight of the gums or hy- turing practice as a formulation aid, drophilic colloids. processing aid, stabilizer and thick- (d) As an emulsifying agent for cocoa ener, and texturizer in foods for which fat in noncarbonated beverages con- standards of identity established under taining cocoa, whereby the amount of

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00093 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.811 21 CFR Ch. I (4–1–11 Edition)

the additive does not exceed 25 parts Uses Limitations per million of the finished beverage. 1. As a crystallization accel- Not to exceed 1 percent of (e) As a dispersing agent in ‘‘cocoa erator in cocoa products, in the combined weight of with dioctyl sodium sulfosuccinate for imitation chocolate, and in the formulation. manufacturing’’ that conforms to the compound coatings. provisions of § 163.117 of this chapter 2. As a formulation aid as de- Not to exceed 0.5 percent. fined in § 170.3(o)(14) of this and the use limitations prescribed in chapter, lubricant and release § 172.520, in an amount not to exceed 0.4 agent as defined in percent by weight thereof. § 170.3(o)(18) of this chapter, and surface-finishing agent as (f) As a processing aid and wetting defined in § 170.3(o)(30) of agent in combination with a-hydro- this chapter in food. omega -hydroxy - poly(oxyethylene) - 3. As a formulation aid as de- Not to exceed 3.0 percent poly-(oxypropylene) (53–59 moles) fined in § 170.3(o)(14) of this of the combined weight chapter in confections. of the formulation. poly(oxyethylene) (14–16 moles) block 4. As a formulation aid as de- Not to exceed 1.0 percent copolymer, having a molecular weight fined in § 170.3(o)(14) of this of the combined weight range of 3,500–4,125 and a cloud point of chapter in fats and oils as de- of the formulation. ° ° fined in § 170.3 (n)(12) of this 9 C–12 C in 10 percent aqueous solu- chapter. tion, for fumaric acid used in fumaric 5. As a winterization and frac- Not to exceed 0.5 percent acid-acidulated dry beverage base and tionation aid in fat and oil by weight of the proc- in fumaric acid-acidulated fruit juice processing. essed fat or oil. drinks, when standards of identity do not preclude such use. The labeling of (d) To assure safe use of the additive: the dry beverage base shall bear ade- (1) In addition to the other informa- quate directions for use, and the addition required by the act, the label or tives shall be used in such an amount labeling of the additive shall bear the that the finished beverage or fruit juice name of the additive. drink will contain not in excess of a (2) The label of the additive shall total of 10 parts per million of the bear adequate directions to provide a dioctyl sodium sulfosuccinate-block final product that complies with the copolymer combination. limitations prescribed in paragraph (c) [42 FR 14491, Mar. 15, 1977, as amended at 49 of this section. FR 10105, Mar. 19, 1984] [53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994] § 172.811 Glyceryl tristearate. The food additive glyceryl tristearate § 172.812 Glycine. may be safely used in food in accord- The food additive glycine may be ance with the following prescribed con- safely used for technological purposes ditions: in food in accordance with the fol- (a) The food additive (CAS Reg. No. lowing prescribed conditions: 555–43–1) is prepared by reacting stearic (a) The additive complies with the acid with glycerol in the presence of a specifications of the ‘‘Food Chemicals suitable catalyst. Codex,’’ 3d Ed. (1981), p. 140, which is in- (b) The food additive meets the fol- corporated by reference. Copies may be lowing specifications: obtained from the National Academy Acid number: Not to exceed 1.0. Press, 2101 Constitution Ave. NW., Iodine number: Not to exceed 1.0. Washington, DC 20418, or may be exam- Saponification number: 186–192. ined at the National Archives and Hydroxyl number: Not to exceed 5.0. Records Administration (NARA). For Free glycerol content: Not to exceed 0.5 per- information on the availability of this cent. material at NARA, call 202–741–6030, or Unsaponifiable matter: Not to exceed 0.5 per- go to: http://www.archives.gov/ cent. federal register/ Melting point (Class II): 69 °C–73 °C. l codeloflfederallregulations/ (c) The additive is used or intended ibrllocations.html. for use as follows when standards of (b) The additive is used or intended identity established under section 401 for use as follows: of the Act do not preclude such use:

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00094 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.818

Uses Limitations § 172.816 Methyl glucoside-coconut oil ester. As a masking agent for the Not to exceed 0.2 percent in bitter aftertaste of sac- the finished beverage. Methyl glucoside-coconut oil ester charin used in manufac- may be safely used in food in accord- tured beverages and bev- ance with the following conditions: erage bases. As a stabilizer in mono- and Not to exceed 0.02 percent of (a) It is the methyl glucoside-coconut diglycerides prepared by the mono- and oil ester having the following specifica- the glycerolysis of edible diglycerides. tions: fats or oils. Acid number: 10–20 (c) To assure safe use of the additive, Hydroxyl number: 200–300 in addition to the other information re- pH (5% aqueous): 4.8–5.0 Saponification number: 178–190 quired by the Act: (1) The labeling of the additive shall (b) It is used or intended for use as bear adequate directions for use of the follows: additive in compliance with the provi- (1) As an aid in crystallization of su- sions of this section. crose and dextrose at a level not to exceed the minimum quantity required to (2) The labeling of beverage bases produce its intended effect. containing the additive shall bear ade- (2) As a surfactant in molasses at a quate directions for use to provide that level not to exceed 320 parts per million beverages prepared therefrom shall in the molasses. contain no more than 0.2 percent glycine. § 172.818 Oxystearin. [42 FR 14491, Mar. 15, 1977, as amended at 49 The food additive oxystearin may be FR 10105, Mar. 19, 1984] safely used in foods, when such use is not precluded by standards of identity § 172.814 Hydroxylated lecithin. in accordance with the following condi- The food additive hydroxylated tions: (a) The additive is a mixture of the lecithin may be safely used as an emul- glycerides of partially oxidized stearic sifier in foods in accordance with the and other fatty acids obtained by heat- following conditions: ing hydrogenated cottonseed or soy- (a) The additive is obtained by the bean oil under controlled conditions, in treatment of lecithin in one of the fol- the presence of air and a suitable cata- lowing ways, under controlled condi- lyst which is not a food additive as so tions whereby the separated fatty acid defined. The resultant product meets fraction of the resultant product has the following specifications: an acetyl value of 30 to 38: Acid number: Maximum 15. (1) With hydrogen peroxide, benzoyl Iodine number: Maximum 15. peroxide, lactic acid, and sodium hy- Saponification number: 225–240. droxide. Hydroxyl number: 30–45. (2) With hydrogen peroxide, acetic Unsaponifiable material: Maximum 0.8 per- acid, and sodium hydroxide. cent. Refractive index (butyro): 60±1 at 48 °C. (b) It is used or intended for use, in accordance with good manufacturing (b) It is used or intended for use as a practice, as an emulsifier in foods, ex- crystallization inhibitor in vegetable cept for those standardized foods that oils and as a release agent in vegetable do not provide for such use. oils and vegetable shortenings, where- (c) To assure safe use of the additive, by the additive does not exceed 0.125 the label of the food additive container percent of the combined weight of the oil or shortening. shall bear, in addition to the other in- (c) To insure safe use of the additive, formation required by the Act: the label and labeling of the additive (1) The name of the additive, container shall bear, in addition to the ‘‘hydroxylated lecithin’’. other information required by the Act: (2) Adequate directions for its use. (1) The name of the additive. (2) Adequate directions to provide an oil or shortening that complies with

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00095 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.820 21 CFR Ch. I (4–1–11 Edition)

the limitations prescribed in paragraph SX850, or equivalent) 12 percent in H2O by (b) of this section. weight on 60–80 mesh nonacid washed diato- maceous earth (Chromosorb W. Johns-Man- § 172.820 Polyethylene glycol (mean ville, or equivalent). molecular weight 200–9,500). REAGENTS AND MATERIALS Polyethylene glycol identified in this Carrier gas, nitrogen: Commercial grade in section may be safely used in food in cylinder equipped with reducing regulator to accordance with the following pre- provide 50 p.s.i.g. to the gas chromatograph. scribed conditions: Ethylene glycol: Commercial grade. Purify (a) Identity. (1) The additive is an ad- if necessary, by distillation. dition polymer of ethylene oxide and Diethylene glycol: Commercial grade. Pu- water with a mean molecular weight of rify, if necessary, by distillation. 200 to 9,500. Glycol standards: Prepare (2) It contains no more than 0.2 per- chromatographic standards by dissolving known amounts of ethylene glycol and cent total by weight of ethylene and diethylene glycol in water. Suitable con- diethylene glycols when tested by the centrations for standardization range from 1 analytical methods prescribed in para- to 6 milligrams of each component per milli- graph (b) of this section. liter (for example 10 milligrams diluted to (b) Analytical method. (1) The analyt- volume in a 10-milliliter volumetric flask is ical method prescribed in the National equivalent to 1 milligram per milliliter). Formulary XV (1980), page 1244, for pol- STANDARDIZATION yethylene glycol 400 shall be used to determine the total ethylene and Inject a 2-microliter aliquot of the glycol diethylene glycol content of poly- standard into the gas chromatograph em- ploying the conditions described above. ethylene glycols having mean molec- Measure the net peak heights for the ethyl- ular weights of 450 or higher. ene glycol and for the diethylene glycol. (2) The following analytical method Record the values as follows: shall be used to determine the total A=Peak height in millimeters of the ethyl- ethylene and diethylene glycol content ene glycol peak. of polyethylene glycols having mean B=milligrams of ethylene glycol per milli- molecular weights below 450. liter of standard solution. C=Peak height in millimeters of the diethylene glycol peak. ANALYTICAL METHOD D=Milligrams of diethylene glycol per milliliter of standard solution. ETHYLENE GLYCOL AND DIETHYLENE GLYCOL CONTENT OF POLYETHYLENE GLYCOLS PROCEDURE The analytical method for determining Weigh approximately 4 grams of polyethylene glycol and diethylene glycol is as ethylene glycol sample accurately into a 10- follows: milliliter volumetric flask. Dilute to volume with water. Mix the solution thoroughly and APPARATUS inject a 2-microliter aliquot into the gas Gas chromatograph with hydrogen flame chromatograph. Measure the heights, in mil- ionization detector (Varian Aerograph 600 D limeters, of the ethylene glycol peak and of or equivalent). The following conditions the diethylene glycol peak and record as E shall be employed with the Varian and F, respectively. Aerograph 600 D gas chromatograph: × × Column temperature: 165 °C. Percent ethylene glycol=(E B)/(A sample Inlet temperature: 260 °C. weight in grams) Carrier gas (nitrogen) flow rate: 70 milli- Percent diethylene glycol=(F×D)/(C×sample liters per minute. weight in grams) Hydrogen and air flow to burner: Optimize to give maximum sensitivity. (c) Uses. It may be used, except in Sample size: 2 microliters. milk or preparations intended for addi- Elution time: Ethylene glycol: 2.0 minutes. tion to milk, as follows: Diethylene glycol: 6.5 minutes. (1) As a coating, binder, plasticizing Recorder: ¥0.5 to +1.05 millivolt, full span, agent, and/or lubricant in tablets used 1 second full response time. for food. Syringe: 10-microliter (Hamilton 710 N or equivalent). (2) As an adjuvant to improve flavor Chromatograph column: 5 feet × 1⁄8 inch. and as a bodying agent in nonnutritive I.D. stainless steel tube packed with sorbitol sweeteners identified in § 180.37 of this (Mathieson-Coleman-Bell 2768 Sorbitol chapter.

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00096 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.824

(3) As an adjuvant in dispersing vita- step is followed by a conventional re- min and/or mineral preparations. fining process that includes alkali neu- (4) As a coating on sodium nitrite to tralization and deodorization of the inhibit hygroscopic properties. fats and oils. (d) Limitations. (1) It is used in an (c) To insure the safe use of the addi- amount not greater than that required tive, the label of the food additive con- to produce the intended physical or tainer shall bear, in addition to the technical effect. other information required by the Act: (2) A tolerance of zero is established (1) The name of the additive, sodium for residues of polyethylene glycol in lauryl sulfate. milk. (2) Adequate use directions to provide [42 FR 14491, Mar. 15, 1977, as amended at 49 a final product that complies with the FR 10105, Mar. 19, 1984] limitations prescribed in paragraph (b) of this section. § 172.822 Sodium lauryl sulfate. The food additive sodium lauryl sul- [42 FR 14491, Mar. 15, 1977, as amended at 43 fate may be safely used in food in ac- FR 18668, May 2, 1978] cordance with the following conditions: (a) The additive meets the following § 172.824 Sodium mono- and dimethyl naphthalene sulfonates. specifications: (1) It is a mixture of sodium alkyl The food additive sodium mono- and sulfates consisting chiefly of sodium dimethyl naphthalene sulfonates may lauryl sulfate [CH2(CH2)10CH2OSO2Na]. be safely used in accordance with the (2) It has a minimum content of 90 following prescribed conditions: percent sodium alkyl sulfates. (a) The additive has a molecular (b) It is used or intended for use: weight range of 245–260. (1) As an emulsifier in or with egg (b) The additive is used or intended whites whereby the additive does not for use: exceed the following limits: (1) In the crystallization of sodium Egg white solids, 1,000 parts per million. carbonate in an amount not to exceed Frozen egg whites, 125 parts per million. 250 parts per million of the sodium car- Liquid egg whites, 125 parts per million. bonate. Such sodium carbonate is used (2) As a whipping agent at a level not or intended for use in potable water to exceed 0.5 percent by weight of gela- systems to reduce hardness and aid in tine used in the preparation of marsh- sedimentation and coagulation by rais- mallows. ing the pH for the efficient utilization (3) As a surfactant in: of other coagulation materials. (i) Fumaric acid-acidulated dry bev- (2) As an anticaking agent in sodium erage base whereby the additive does nitrite at a level not in excess of 0.1 not exceed 25 parts per million of the percent by weight thereof for author- finished beverage and such beverage ized uses in cured fish and meat. base is not for use in a food for which (c) In addition to the general labeling a standard of identity established requirements of the Act: under section 401 of the Act precludes (1) Sodium carbonate produced in ac- such use. cordance with paragraph (b)(1) of this (ii) Fumaric acid-acidulated fruit section shall be labeled to show the juice drinks whereby the additive does presence of the additive and its label or not exceed 25 parts per million of the labeling shall bear adequate directions finished fruit juice drink and it is not for use. used in a fruit juice drink for which a (2) Sodium nitrite produced in ac- standard of identity established under cordance with paragraph (b)(2) of this section 401 of the Act precludes such section shall bear the labeling required use. by § 172.175 and a statement declaring (4) As a wetting agent at a level not the presence of sodium mono- and di- to exceed 10 parts per million in the partition of high and low melting frac- methyl naphthalene sulfonates. tions of crude vegetable oils and ani- [42 FR 14491, Mar. 15, 1977, as amended at 63 mal fats, provided that the partition FR 7069, Feb. 12, 1998]

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00097 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.826 21 CFR Ch. I (4–1–11 Edition)

§ 172.826 Sodium stearyl fumarate. essing, food-packing, or food-storage Sodium stearyl fumarate may be equipment. safely used in food in accordance with [42 FR 14491, Mar. 15, 1977, as amended at 50 the following conditions: FR 3508, Jan. 25, 1985] (a) It contains not less than 99 percent sodium stearyl fumarate cal- § 172.829 Neotame. culated on the anhydrous basis, and (a) Neotame is the chemical N-[N- not more than 0.25 percent sodium ste- (3,3-dimethylbutyl)-L-a-aspartyl]-L- aryl maleate. phenylalanine-1-methyl ester (CAS (b) The additive is used or intended Reg. No. 165450–17–9). for use: (1) As a dough conditioner in yeast- (b) Neotame meets the following leavened bakery products in an amount specifications when it is tested accord- not to exceed 0.5 percent by weight of ing to the methods described or ref- the flour used. erenced in the document entitled (2) As a conditioning agent in dehy- ‘‘Specifications and Analytical Meth- drated potatoes in an amount not to ods for Neotame’’ dated April 3, 2001, exceed 1 percent by weight thereof. by the NutraSweet Co., 699 North (3) As a stabilizing agent in Wheeling Rd., Mount Prospect, IL nonyeast-leavened bakery products in 60056. The Director of the Office of the an amount not to exceed 1 percent by Federal Register has approved the in- weight of the flour used. corporation by reference of this mate- (4) As a conditioning agent in proc- rial in accordance with 5 U.S.C. 552(a) essed cereals for cooking in an amount and 1 CFR part 51. Copies are available not to exceed 1 percent by weight of from the Office of Food Additive Safety the dry cereal, except for foods for (HFS–200), Center for Food Safety and which standards of identity preclude Applied Nutrition, 5100 Paint Branch such use. Pkwy., College Park, MD 20740. Copies (5) As a conditioning agent in starch- may be examined at the Center for thickened or flour-thickened foods in Food Safety and Applied Nutrition’s an amount not to exceed 0.2 percent by Library, 5100 Paint Branch Pkwy., rm. weight of the food. 1C–100, College Park, MD 20740, or at the National Archives and Records Ad- § 172.828 Acetylated monoglycerides. ministration (NARA). For information The food additive acetylated on the availability of this material at monoglycerides may be safely used in NARA, call 202–741–6030, or go to: http:// or on food in accordance with the fol- www.archives.gov/federallregister/ lowing prescribed conditions: codeloflfederallregulations/ (a) The additive is manufactured by: ibrllocations.html. (1) The interesterification of edible (1) Assay for neotame, not less than fats with triacetin and in the presence 97.0 percent and not more than 102.0 of catalytic agents that are not food percent on a dry basis. additives or are authorized by regula- (2) Free dipeptide acid (N-[N-(3,3- tion, followed by a molecular distilla- dimethylbutyl)-L-a-aspartyl]-L- tion or by steam stripping; or phenylalanine), not more than 1.5 per- (2) The direct acetylation of edible cent. monoglycerides with acetic anhydride (3) Other related substances, not without the use of catalyst or molec- more than 2.0 percent. ular distillation, and with the removal (4) Lead, not more than 2.0 milli- by vacuum distillation, if necessary, of the acetic acid, acetic anhydride, and grams per kilogram. triacetin. (5) Water, not more than 5.0 percent. (b) The food additive has a Reichert- (6) Residue on ignition, not more Meissl value of 75–200 and an acid value than 0.2 percent of less than 6. (7) Specific rotation, determined at (c) The food additive is used at a 20 °C [a]D: ¥40.0° to 43.4° calculated on level not in excess of the amount rea- a dry basis. sonably required to produce its in- (c) The food additive neotame may be tended effect in food, or in food-proc- safely used as a sweetening agent and

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00098 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.832

flavor enhancer in foods generally, ex- (b) The additive meets the specifica- cept in meat and poultry, in accord- tions of the ‘‘Food Chemicals Codex,’’ ance with current good manufacturing 4th ed. (1996), pp. 398–400, which is in- practice, in an amount not to exceed corporated by reference in accordance that reasonably required to accomplish with 5 U.S.C. 552(a) and 1 CFR part 51. the intended technical effect, in foods Copies are available from the Division for which standards of identity estab- of Product Policy (HFS–206), Center for lished under section 401 of the Federal Food Safety and Applied Nutrition, Food, Drug, and Cosmetic Act do not Food and Drug Administration, 5100 preclude such use. Paint Branch Pkwy., College Park, MD (d) When neotame is used as a sugar 20740, or may be examined at the Cen- substitute tablet, L-leucine may be ter for Food Safety and Applied Nutri- used as a lubricant in the manufacture tion’s Library, 5100 Paint Branch of tablets at a level not to exceed 3.5 Pkwy., College Park, MD 20740, or at percent of the weight of the tablet. the National Archives and Records Ad- (e) If the food containing the additive ministration (NARA). For information purports to be or is represented to be on the availability of this material at for special dietary use, it shall be la- NARA, call 202–741–6030, or go to: http:// beled in compliance with part 105 of www.archives.gov/federallregister/ this chapter. codeloflfederallregulations/ [67 FR 45310, July 9, 2002] ibrllocations.html. (c) The additive may be used as a § 172.830 Succinylated monoglycerides. sweetener in foods generally, in accord- The food additive succinylated ance with current good manufacturing monoglycerides may be safely used in practice in an amount not to exceed food in accordance with the following that reasonably required to accomplish prescribed conditions: the intended effect. (a) The additive is a mixture of semi- (d) If the food containing the additive and neutral succinic acid esters of purports to be or is represented to be mono- and diglycerides produced by the for special dietary use, it shall be la- succinylation of a product obtained by beled in compliance with part 105 of the glycerolysis of edible fats and oils, this chapter. or by the direct esterification of glyc- [63 FR 16433, Apr. 3, 1998, as amended at 64 erol with edible fat-forming fatty FR 43909, Aug. 12, 1999] acids. (b) The additive meets the following § 172.832 Monoglyceride citrate. specifications: A food additive that is a mixture of Succinic acid content: 14.8%–25.6% glyceryl monooleate and its citric acid Melting point: 50 °C–60 °C. monoester manufactured by the reac- Acid number: 70–120 tion of glyceryl monooleate with citric (c) The additive is used or intended acid under controlled conditions may for use in the following foods: be safely used as a synergist and solu- (1) As an emulsifier in liquid and bilizer for antioxidants in oils and fats, plastic shortenings at a level not to ex- when used in accordance with the con- ceed 3 percent by weight of the short- ditions prescribed in this section. ening. (a) The food additive meets the fol- (2) As a dough conditioner in bread lowing specifications: baking, when such use is permitted by an appropriate food standard, at a level Acid number, 70–100. not to exceed 0.5 percent by weight of Total citric acid (free and combined), 14 percent–17 percent. the flour used. (b) It is used, or intended for use, in § 172.831 Sucralose. antioxidant formulations for addition (a) Sucralose is the chemical 1,6- to oils and fats whereby the additive dichloro-1,6-dideoxy-b-D- does not exceed 200 parts per million of fructofuranosyl-4-chloro-4-deoxy-a-D- the combined weight of the oil or fat galactopyranoside (CAS Reg. No. 56038– and the additive. 13–2). (c) To assure safe use of the additive:

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00099 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.833 21 CFR Ch. I (4–1–11 Edition)

(1) The container label shall bear, in codeloflfederallregulations/ addition to the other information re- ibrllocations.html. quired by the Act, the name of the ad- (3) Acid value: Not to exceed 0.20 de- ditive. termined using 50 grams of sample by (2) The label or accompanying label- the ‘‘Guide to Specifications for Gen- ing shall bear adequate directions for eral Notices, General Analytical Tech- the use of the additive which, if fol- niques, Identification Tests, Test Solu- lowed, will result in a food that com- tions, and Other Reference Materials,’’ plies with the requirements of this sec- in the ‘‘Compendium of Food Additive tion. Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 2,’’ p. § 172.833 Sucrose acetate isobutyrate 189 (1991), which is incorporated by ref- (SAIB). erence; see paragraph (b)(2) of this sec- Sucrose acetate isobutyrate may be tion for availability of the incorpora- safely used in foods in accordance with tion by reference. the following prescribed conditions: (4) Lead: Not to exceed 1.0 milli- (a) Sucrose acetate isobutyrate (CAS grams/kilogram determined by the Reg. No. 27216–37–1), or SAIB, is the ‘‘Atomic Absorption chemical alpha-D-glucopyranoside, O- Spectrophotometric Graphite Furnace acetyl-tris-O-(2-methyl-1-oxopropyl)- Method, Method I,’’ in the ‘‘Food beta-D-fructofuranosyl, acetate tris(2- Chemicals Codex,’’ 4th ed. (1996), pp. 763 methyl propanoate). and 764, with an attached modification (b) SAIB, a pale, straw-colored liquid, to the sample digestion section in Ap- meets the following specifications: (1) pendix III.B (July 1996), which is incor- Assay: Not less than 98.8 percent and porated by reference. Copies are avail- not more than 101.9 percent, based on able from the National Academy Press, the following formula: 2101 Constitution Ave. NW., Box 285, Washington, DC 20055 (Internet http:// Assay = ((SV 0.10586) ÷ 56.1) × 100 www.nap.edu), or may be examined at the Center for Food Safety and Applied Where SV = Saponification value Nutrition’s Library, 5100 Paint Branch (2) Saponification value: 524–540 de- Pkwy., College Park, MD 20740, or at termined using 1 gram of sample by the the National Archives and Records Ad- ‘‘Guide to Specifications for General ministration (NARA). For information Notices, General Analytical Tech- on the availability of this material at niques, Identification Tests, Test Solu- NARA, call 202–741–6030, or go to: http:// tions, and Other Reference Materials,’’ www.archives.gov/federallregister/ in the ‘‘Compendium of Food Additive codeloflfederallregulations/ Specifications, Addendum 4, Food and ibrllocations.html. Agriculture Organization of the United (5) Triacetin: Not to exceed 0.10 per- Nations (FAO), Food and Nutrition cent determined by gas chroma- Paper 5, Revision 2’’ (1991), pp. 203 and tography as described in the ‘‘Guide to 204, which is incorporated by reference, Specifications for General Notices, in accordance with 5 U.S.C. 552(a) and 1 General Analytical Techniques, Identi- CFR part 51. Copies are available from fication Tests, Test Solutions, and the Office of Premarket Approval, Cen- Other Reference Materials,’’ in the ter for Food Safety and Applied Nutri- ‘‘Compendium of Food Additive Speci- tion (HFS–200), Food and Drug Admin- fications, Addendum 4, FAO Food and istration, 5100 Paint Branch Pkwy., Nutrition Paper 5, Revision 2,’’ (1991), College Park, MD 20740, or may be ex- pp. 13–26, which is incorporated by ref- amined at the Center for Food Safety erence; see paragraph (b)(2) of this sec- and Applied Nutrition’s Library, 5100 tion for availability of the incorpora- Paint Branch Pkwy., College Park, MD tion by reference. 20740, or at the National Archives and (c) The food additive is used as a sta- Records Administration (NARA). For bilizer (as defined in § 170.3(o)(28) of this information on the availability of this chapter) of emulsions of flavoring oils material at NARA, call 202–741–6030, or in nonalcoholic beverages. go to: http://www.archives.gov/ (d) The total SAIB content of a bev- federallregister/ erage containing the additive does not

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00100 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.836

exceed 300 milligrams/kilogram of the (d) When the name ‘‘polyglycerate finished beverage. 60’’ is used in labeling it shall be followed by either ‘‘polyoxyethylene (20) [64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999] mono-and diglycerides of fatty acids’’ or ‘‘ethoxylated mono- and § 172.834 Ethoxylated mono- and diglycerides’’ in parentheses. diglycerides. [42 FR 14491, Mar. 15, 1977, as amended at 42 The food additive ethoxylated mono- FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, and diglycerides (polyoxyethylene (20) 1985] mono- and diglycerides of fatty acids) § 172.836 Polysorbate 60. (polyglycerate 60) may be safely used in food in accordance with the fol- The food additive polysorbate 60 lowing prescribed conditions: (polyoxyethylene (20) sorbitan mono- (a) The food additive is manufactured stearate) which is a mixture of by: polyoxyethylene ethers of mixed par- (1) Glycerolysis of edible fats pri- tial stearic and palmitic acid esters of marily composed of stearic, palmitic, sorbitol anhydrides and related com- and myristic acids; or pounds, may be safely used in food in (2) Direct esterification of glycerol accordance with the following pre- with a mixture of primarily stearic, scribed conditions: palmitic, and myristic acids; (a) The food additive is manufactured by reacting stearic acid (usually con- to yield a product with less than 0.3 taining associated fatty acids, chiefly acid number and less than 0.2 percent palmitic) with sorbitol to yield a prod- water, which is then reacted with uct with a maximum acid number of 10 ethylene oxide. and a maximum water content of 0.2 (b) The additive meets the following percent, which is then reacted with specifications: ethylene oxide. (b) The food additive meets the fol- Saponification number, 65–75. lowing specifications: Acid number, 0–2. Hydroxyl number, 65–80. Saponification number 45–55. Oxyethylene content, 60.5–65.0 percent. Acid number 0–2. Hydroxyl number 81–96. (c) The additive is used or intended Oxyethylene content 65 percent–69.5 percent. for use in the following foods when standards of identity established under (c) It is used or intended for use as section 401 of the Act do not preclude follows: such use: (1) As an emulsifier in whipped edible oil topping with or without one or a Use Limitations combination of the following: (i) Sorbitan monostearate; 1. As an emulsifier in pan-re- Not to exceed levels required (ii) Polysorbate 65; lease agents for and as a to produce the intended ef- dough conditioner in yeast- fects, total not to exceed (iii) Polysorbate 80; leavened bakery products. 0.5 percent by weight of the flour used. whereby the maximum amount of the 2. As an emulsifier in cakes Not to exceed 0.5 percent by additive or additives used does not ex- and cake mixes. weight of the dry ingredi- ceed 0.4 percent of the weight of the ents. finished whipped edible oil topping; ex- 3. As an emulsifier in Not to exceed 0.45 percent whipped vegetable oil top- by weight of the finished cept that a combination of the additive pings and topping mixes. whipped vegetable oil top- with sorbitan monostearate may be pings. used in excess of 0.4 percent, provided 4. As an emulsifier in icings Not to exceed 0.5 percent by that the amount of the additive does and icing mixes. weight of the finished icings. not exceed 0.77 percent and the amount 5. As an emulsifier in frozen Not to exceed 0.2 percent by of sorbitan monostearate does not ex- desserts. weight of the finished fro- ceed 0.27 percent of the weight of the zen desserts. finished whipped edible oil topping. 6. As an emulsifier in edible Not to exceed 0.4 percent by vegetable fat-water emul- weight of the finished vege- (2) As an emulsifier in cakes and cake sions intended for use as table fat-water emulsions. mixes, with or without one or a com- substitutes for milk or bination of the following: cream in beverage coffee. (i) Polysorbate 65.

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00101 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.836 21 CFR Ch. I (4–1–11 Edition)

(ii) Sorbitan monostearate. (7) As an emulsifier in nonstandardized dressings whereby the maximum When used alone, the maximum amount of the additive does not exceed amount of polysorbate 60 shall not ex- 0.3 percent of the weight of the finished ceed 0.46 percent of the cake or cake dressings. mix, on a dry-weight basis. When used (8) As an emulsifier, alone or in com- with polysorbate 65 and/or sorbitan bination with polysorbate 80, in monostearate, it shall not exceed 0.46 shortenings and edible oils intended for percent, nor shall the polysorbate 65 use in foods as follows, when standards exceed 0.32 percent or the sorbitan of identity established under section monostearate exceed 0.61 percent, and 401 of the act do not preclude such use: no combination of these emulsifiers (i) It is used alone in an amount not shall exceed 0.66 percent of the cake or to exceed 1 percent of the weight of the cake mix, all calculated on a dry- finished shortening or oil. weight basis. (ii) It is used with polysorbate 80 in (3) As an emulsifier, alone or in com- any combination providing no more bination with sorbitan monostearate, than 1 percent of polysorbate 60 and no in nonstandardized confectionery coat- more than 1 percent of polysorbate 80, ings and standardized cacao products provided that the total combination specified in §§ 163.123, 163.130, 163.135, does not exceed 1 percent of the fin- 163.140, 163.145, and 163.150 of this chap- ished shortening or oil. ter, as follows: (iii) The 1–percent limitation speci- (i) It is used alone in an amount not fied in paragraph (c)(8) (i) and (ii) of to exceed 0.5 percent of the weight of this section may be exceeded in premix the finished nonstandardized confec- concentrates of shortening or edible oil tionery coating or standardized cacao if the labeling complies with the re- product. quirements of paragraph (d) of this sec- (ii) It is used with sorbitan mono- tion. stearate in any combination of up to (9) As an emulsifier in solid-state, ed- 0.5 percent of polysorbate 60 and up to ible vegetable fat-water emulsions in- 1 percent of sorbitan monostearate: tended for use as substitutes for milk Provided, That the total combination or cream in beverage coffee, with or does not exceed 1 percent of the weight without one or a combination of the of the finished nonstandardized confec- following: tionery coating or standardized cacao (i) Polysorbate 65. product. (ii) Sorbitan monostearate. (4) [Reserved] The maximum amount of the additive (5) As an emulsifier in cake icings or additives shall not exceed 0.4 per- and cake fillings, with or without one cent by weight of the finished edible or a combination of the following: vegetable fat-water emulsion. (i) Polysorbate 65. (10) As a foaming agent in non- (ii) Sorbitan monostearate. alcoholic mixes, to be added to alco- When used alone, the maximum holic beverages in the preparation of amount of polysorbate 60 shall not ex- mixed alcoholic drinks, at a level not ceed 0.46 percent of the weight of the to exceed 4.5 percent by weight of the cake icings and cake fillings. When nonalcoholic mix. used with polysorbate 65 and/or sorbi- (11) As a dough conditioner in yeast- tan monostearate, it shall not exceed leavened bakery products in an amount 0.46 percent, nor shall the polysorbate not to exceed 0.5 percent by weight of 65 exceed 0.32 percent or the sorbitan the flour used. monostearate exceed 0.7 percent, and (12) As an emulsifier, alone or in no combination of these emulsifiers combination with sorbitan monostea- shall exceed 1 percent of the weight of rate, in the minimum quantity re- the cake icing or cake filling. quired to accomplish the intended ef- (6) To impart greater opacity to fect, in formulations of white mineral sugar-type confection coatings where- oil conforming with § 172.878 and/or pe- by the maximum amount of the addi- troleum wax conforming with § 172.886 tive does not exceed 0.2 percent of the for use as protective coatings on raw weight of the finished sugar coating. fruits and vegetables.

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00102 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.838

(13) As a dispersing agent in artifi- tristearate), which is a mixture of cially sweetened gelatin desserts and in polyoxyethylene ethers of mixed ste- artificially sweetened gelatin dessert aric acid esters of sorbitol anhydrides mixes, whereby the amount of the addi- and related compounds, may be safely tive does not exceed 0.5 percent on a used in food in accordance with the fol- dry-weight basis. lowing prescribed conditions: (14) As an emulsifier in chocolate fla- (a) The food additive is manufactured vored syrups, whereby the maximum by reacting stearic acid (usually con- amount of the additive does not exceed taining associated fatty acids, chiefly 0.05 percent in the finished product. palmitic) with sorbitol to yield a prod- (15) As a surfactant and wetting uct with a maximum acid number of 15 agent for natural and artificial colors and a maximum water content of 0.2 in food as follows: percent, which is then reacted with (i) In powdered soft drink mixes in an ethylene oxide. amount not to exceed 4.5 percent by (b) The food additive meets the fol- weight of the mix. lowing specifications: (ii) In sugar-based gelatin dessert Saponification number 88–98. mixes in an amount not to exceed 0.5 Acid number 0–2. percent by weight of the mix. Hydroxyl number 44–60. (iii) In artificially sweetened gelatin Oxyethylene content 46 percent–50 percent. dessert mixes in an amount not to ex- (c) The additive is used, or intended ceed 3.6 percent by weight of the mix. for use, as follows: (iv) In sugar-based pudding mixes in (1) As an emulsifier in ice cream, fro- an amount not to exceed 0.5 percent by zen custard, ice milk, fruit sherbet and weight of the mix. nonstandardized frozen desserts when (v) In artificially sweetened pudding used alone or in combination with mixes in an amount not to exceed 0.5 polysorbate 80, whereby the maximum percent by weight of the mix. amount of the additives, alone or in (16) As an emulsifier in ice cream, combination, does not exceed 0.1 per- frozen custard, fruit sherbet, and non- cent of the finished frozen dessert. standardized frozen desserts when used (2) As an emulsifier in cakes and cake alone or in combination with poly- mixes, with or without one or a com- sorbate 65 and/or polysorbate 80, where- bination of the following: by the maximum amount of the addi- (i) Sorbitan monostearate. tives, alone or in combination, does not (ii) Polysorbate 60. exceed 0.1 percent of the finished frozen dessert. When used alone, the maximum (d) To assure safe use of the additive, amount of polysorbate 65 shall not ex- in addition to the other information re- ceed 0.32 percent of the cake or cake quired by the Act: mix, on a dry-weight basis. When used (1) The label of the additive and any with sorbitan monostearate and/or intermediate premixes shall bear: polysorbate 60, it shall not exceed 0.32 (i) The name of the additive. percent, nor shall the sorbitan mono- (ii) A statement of the concentration stearate exceed 0.61 percent or the or strength of the additive in any in- polysorbate 60 exceed 0.46 percent, and termediate premixes. no combination of these emulsifiers (2) The label or labeling shall bear shall exceed 0.66 percent of the cake or adequate directions to provide a final cake mix, all calculated on a dry- product that complies with the limita- weight basis. tions prescribed in paragraph (c) of this (3) As an emulsifier in whipped edible section. oil topping with or without one or a combination of the following: [42 FR 14491, Mar. 15, 1977, as amended at 43 (i) Sorbitan monostearate; FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, (ii) Polysorbate 60; 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct. 28, 1999] (iii) Polysorbate 80; whereby the maximum amount of the § 172.838 Polysorbate 65. additive or additives used does not ex- The food additive polysorbate 65 ceed 0.4 percent of the weight of the (polyoxyethylene (20) sorbitan finished whipped edible oil topping.

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00103 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.840 21 CFR Ch. I (4–1–11 Edition)

(4) As an emulsifier in solid-state, ed- sorbitol to yield a product with a max- ible vegetable fat-water emulsions in- imum acid number of 7.5 and a max- tended for use as substitutes for milk imum water content of 0.5 percent, or cream in beverage coffee, with or which is then reacted with ethylene without one or a combination of the oxide. following: (b) The food additive meets the fol- (i) Sorbitan monostearate. lowing specifications: (ii) Polysorbate 60. Saponification number 45–55. The maximum amount of the additive Acid number 0–2. or additives shall not exceed 0.4 per- Hydroxyl number 65–80. cent by weight of the finished edible Oxyethylene content 65 percent–69.5 percent. vegetable fat-water emulsion. (c) The additive is used or intended (5) As an emulsifier in cake icings for use as follows: and cake fillings, with or without one (1) An emulsifier in ice cream, frozen or a combination of the following: custard, ice milk, fruit sherbet, and (i) Sorbitan monostearate. nonstandardized frozen desserts, when (ii) Polysorbate 60. used alone or in combination with polysorbate 65 whereby the maximum When used alone, the maximum amount of the additives, alone or in amount of polysorbate 65 shall not ex- combination, does not exceed 0.1 per- ceed 0.32 percent of the weight of the cent of the finished frozen dessert. cake icing or cake filling. When used (2) In yeast-defoamer formulations with sorbitan monostearate and/or whereby the maximum amount of the polysorbate 60, it shall not exceed 0.32 additive does not exceed 4 percent of percent, nor shall the sorbitan mono- the finished yeast defoamer and the stearate exceed 0.7 percent or the poly- maximum amount of the additive in sorbate 60 exceed 0.46 percent, and no the yeast from such use does not ex- combination of these emulsifiers shall ceed 4 parts per million. exceed 1 percent of the weight of the (3) As a solubilizing and dispersing cake icing or cake filling. agent in pickles and pickle products, (d) To assure safe use of the additive, whereby the maximum amount of the in addition to the other information re- additive does not exceed 500 parts per quired by the Act: million. (1) The label of the additive and any (4) As a solubilizing and dispersing intermediate premixes shall bear: agent in: (i) The name of the additive. (i) Vitamin-mineral preparations (ii) A statement of the concentration containing calcium caseinate in the ab- or strength of the additive in any in- sence of fat-soluble vitamins, whereby termediate premixes. the maximum intake of polysorbate 80 (2) The label or labeling shall bear shall not exceed 175 milligrams from adequate directions to provide a final the recommended daily dose of the product that complies with the limita- preparations. tions prescribed in paragraph (c) of this (ii) Fat-soluble vitamins in vitamin section. and vitamin-mineral preparations con- [42 FR 14491, Mar. 15, 1977, as amended at 43 taining no calcium caseinate, whereby FR 2871, Jan. 20, 1978] the maximum intake of polysorbate 80 shall not exceed 300 milligrams from § 172.840 Polysorbate 80. the recommended daily dose of the The food additive polysorbate 80 preparations. (polyoxyethylene (20) sorbitan (iii) In vitamin-mineral preparations monooleate), which is a mixture of containing both calcium caseinate and polyoxyethylene ethers of mixed par- fat-soluble vitamins, whereby the max- tial oleic acid esters of sorbitol anhy- imum intake of polysorbate 80 shall drides and related compounds, may be not exceed 475 milligrams from the rec- safely used in food in accordance with ommended daily dose of the prepara- the following prescribed conditions: tions. (a) The food additive is manufactured (5) As a surfactant in the production by reacting oleic acid (usually con- of coarse crystal sodium chloride taining associated fatty acids) with whereby the maximum amount of the

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00104 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.841

additive in the finished sodium chlo- prior to application of such dilutions to ride does not exceed 10 parts per mil- the growing crop. Residues resulting lion. from such use are exempt from the re- (6) In special dietary foods, as an quirement of a tolerance. When so used emulsifier for edible fats and oils, with or intended for use, the additive shall directions for use which provide for the be exempt from the requirements of ingestion of not more than 360 milli- paragraph (d)(1) of this section. grams of polysorbate 80 per day. (13) As a defoaming agent in the prep- (7) As a solubilizing and dispersing aration of the creaming mixture for agent for dill oil in canned spiced green cottage cheese and lowfat cottage beans, not to exceed 30 parts per mil- cheese, as identified in §§ 133.128 and lion. 133.131 of this chapter, respectively, (8) As an emulsifier, alone or in com- whereby the amount of the additive bination with polysorbate 60, in does not exceed .008 percent by weight shortenings and edible oils intended for of the finished products. use in foods as follows, when standards (14) As a surfactant and wetting of identity established under section agent for natural and artificial colors 401 of the act do not preclude such use: for use in barbecue sauce where the (i) It is used alone in an amount not level of the additive does not exceed to exceed 1 percent of the weight of the 0.005 percent by weight of the barbecue finished shortening or oil. sauce. (ii) It is used with polysorbate 60 in (d) To assure safe use of the additive, any combination providing no more in addition to the other information re- than 1 percent of polysorbate 80 and no quired by the Act: more than 1 percent of polysorbate 60, (1) The label of the additive and any provided that the total combination intermediate premixes shall bear: does not exceed 1 percent of the fin- (i) The name of the additive. ished shortening or oil. (ii) A statement of the concentration (iii) The 1–percent limitation speci- or strength of the additive in any in- fied in paragraph (c)(8) (i) and (ii) of termediate premixes. this section may be exceeded in premix (2) The label or labeling shall bear concentrates of shortening or edible oil adequate directions to provide a final if the labeling complies with the re- product that complies with the limita- quirements of paragraph (d) of this sections prescribed in paragraph (c) of this tion. section. (9) As an emulsifier in whipped edible [42 FR 14491, Mar. 15, 1977, as amended at 43 oil topping with or without one or a FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, combination of the following: 1980; 46 FR 8466, Jan. 27, 1981] (i) Sorbitan monostearate; (ii) Polysorbate 60; § 172.841 Polydextrose. (iii) Polysorbate 65; Polydextrose as identified in this sec- whereby the maximum amount of the tion may be safely used in food in ac- additive or additives used does not ex- cordance with the following prescribed ceed 0.4 percent of the weight of the conditions: finished whipped edible oil topping. (a)(1) Polydextrose (CAS Reg. No. (10) It is used as a wetting agent in 68424–04–4) is a partially metabolizable scald water for poultry defeathering, water-soluble polymer prepared by the followed by potable water rinse. The condensation of a melt which consists concentration of the additive in the either of approximately 89 percent D- scald water does not exceed 0.0175 per- glucose, 10 percent sorbitol, and 1 percent. cent citric acid or of approximately 90 (11) As a dispersing agent in gelatin percent D-glucose, 10 percent sorbitol, desserts and in gelatin dessert mixes, and 0.1 percent phosphoric acid, on a whereby the amount of the additive weight basis. does not exceed 0.082 percent on a dry- (2) Polydextrose may be partially weight basis. neutralized with potassium hydroxide, (12) As an adjuvant added to herbi- or partially reduced by transition cide use and plant-growth regulator metal catalytic hydrogenation in aque- use dilutions by a grower or applicator ous solution.

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00105 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.842 21 CFR Ch. I (4–1–11 Edition)

(b) The additive meets the specifica- food in accordance with the following tions of the ‘‘Food Chemicals Codex,’’ prescribed conditions: 5th ed. (January 1, 2004), pp. 336–339, (a) The food additive is manufactured and the First Supplement to the 5th by reacting stearic acid (usually con- Edition of the Food Chemicals Codex taining associated fatty acids, chiefly (March 1, 2006), p. 37, which are incor- palmitic) with sorbitol to yield essen- porated by reference. The Director of tially a mixture of esters. the Office of the Federal Register ap- (b) The food additive meets the fol- proves this incorporation by reference lowing specifications: in accordance with 5 U.S.C. 552(a) and 1 Saponification number, 147–157 CFR part 51. You may obtain a copy Acid number, 5–10 from The National Academies Press, Hydroxyl number, 235–260 500 Fifth St. NW., Washington, DC 20001 (c) It is used or intended for use, (Internet address http://www.nap.edu). alone or in combination with poly- You may inspect a copy at the Center sorbate 60 as follows: for Food Safety and Applied Nutri- (1) As an emulsifier in whipped edible tion’s Library, Food and Drug Admin- oil topping with or without one or a istration, 5100 Paint Branch Pkwy., combination of the following: College Park, MD 20740, or at the Na- (i) Polysorbate 60; tional Archives and Records Adminis- (ii) Polysorbate 65; tration (NARA). For information on (iii) Polysorbate 80; the availability of this material at whereby the maximum amount of the NARA, call 202–741–6030, or go to: http:// additive or additives used does not ex- www.archives.gov/federal-register/cfr/ibr- ceed 0.4 percent of the weight of the locations.html. finished whipped edible oil topping; ex- (c) When standards of identity estab- cept that a combination of the additive lished under section 401 of the act do with polysorbate 60 may be used in ex- not preclude such use, polydextrose cess of 0.4 percent: Provided, That the may be used in accordance with cur- amount of the additive does not exceed rent good manufacturing practices as a 0.27 percent and the amount of poly- bulking agent, formulation aid, humec- sorbate 60 does not exceed 0.77 percent tant, and texturizer in all foods, except of the weight of the finished whipped meat and poultry, baby food, and in- edible oil topping. fant formula. (2) As an emulsifier in cakes and cake (d) If the food containing the additive mixes, with or without one or a com- purports to be or is represented for spe- bination of the following: cial dietary uses, it shall be labeled in (i) Polysorbate 65. compliance with part 105 of this chap- (ii) Polysorbate 60. ter. When used alone, the maximum (e) The label and labeling of food a amount of sorbitan monostearate shall single serving of which would be ex- not exceed 0.61 percent of the cake or pected to exceed 15 grams of the addi- cake mix, on a dry-weight basis. When tive shall bear the statement: ‘‘Sen- used with polysorbate 65 and/or poly- sitive individuals may experience a sorbate 60, it shall not exceed 0.61 per- laxative effect from excessive con- cent, nor shall the polysorbate 65 ex- sumption of this product’’. ceed 0.32 percent or the polysorbate 60 [46 FR 30081, June 5, 1981, as amended at 59 exceed 0.46 percent, and no combina- FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, tion of the emulsifiers shall exceed 0.66 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, percent of the weight of the cake or June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR cake mix, calculated on a dry-weight 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000; basis. 72 FR 46564, Aug. 21, 2007] (3) As an emulsifier, alone or in combination with polysorbate 60 in non- § 172.842 Sorbitan monostearate. standardized confectionery coatings The food additive sorbitan monostea- and standardized cacao products speci- rate, which is a mixture of partial ste- fied in §§ 163.123, 163.130, 163.135, 163.140, aric and palmitic acid esters of sorbitol 163.145, and 163.150 of this chapter, as anhydrides, may be safely used in or on follows:

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00106 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.844

(i) It is used alone in an amount not (1) The label of the additive and any to exceed 1 percent of the weight of the intermediate premixes shall bear: finished nonstandardized confectionery (i) The name of the additive. coating or standardized cacao product. (ii) A statement of the concentration (ii) It is used with polysorbate 60 in or strength of the additive in any in- any combination of up to 1 percent sor- termediate premixes. bitan monostearate and up to 0.5 per- (2) The label or labeling shall bear cent polysorbate 60 provided that the adequate directions to provide a final total combination does not exceed 1 product that complies with the limita- percent of the weight of the finished tions prescribed in paragraph (c) of this nonstandardized confectionery coating section. or standardized cacao product. [42 FR 14491, Mar. 15, 1977, as amended at 43 (4) As an emulsifier in cake icings FR 2871, Jan. 20, 1978] and cake fillings, with or without one or a combination of the following: § 172.844 Calcium stearoyl-2-lactylate. (i) Polysorbate 65. The food additive calcium stearoyl-2- (ii) Polysorbate 60. lactylate may be safely used in or on food in accordance with the following When used alone, the maximum prescribed conditions: amount of sorbitan monostearate shall (a) The additive, which is a mixture not exceed 0.7 percent of the weight of of calcium salts of stearoyl lactylic the cake icing or cake filling. When acids and minor proportions of other used with polysorbate 65 and/or poly- calcium salts of related acids, is manu- sorbate 60, it shall not exceed 0.7 per- factured by the reaction of stearic acid cent, nor shall the polysorbate 65 ex- and lactic acid and conversion to the ceed 0.32 percent or the polysorbate 60 calcium salts. exceed 0.46 percent, and no combina- (b) The additive meets the following tion of these emulsifiers shall exceed 1 specifications: percent of the weight of the cake icing or cake filling. Acid number, 50–86. (5) As an emulsifier in solid-state, ed- Calcium content, 4.2–5.2 percent. ible vegetable fat-water emulsions in- Lactic acid content, 32–38 percent. tended for use as substitutes for milk Ester number, 125–164. or cream in beverage coffee, with or (c) It is used or intended for use as without one or a combination of the follows: following: (1) As a dough conditioner in yeast- (i) Polysorbate 60. leavened bakery products and prepared (ii) Polysorbate 65. mixes for yeast-leavened bakery products in an amount not to exceed 0.5 The maximum amount of the additive part for each 100 parts by weight of or additives shall not exceed 0.4 per- flour used. cent by weight of the finished edible (2) As a whipping agent in: vegetable fat-water emulsion. (i) Liquid and frozen egg white at a (6) It is used alone as a rehydration level not to exceed 0.05 percent. aid in the production of active dry (ii) Dried egg white at a level not to yeast in an amount not to exceed 1 per- exceed 0.5 percent. cent by weight of the dry yeast. (iii) Whipped vegetable oil topping at (7) As an emulsifier, alone or in com- a level not to exceed 0.3 percent of the bination with polysorbate 60, in the weight of the finished whipped vege- minimum quantity required to accom- table oil topping. plish the intended effect, in formula- (3) As a conditioning agent in dehy- tions of white mineral oil conforming drated potatoes in an amount not to with § 172.878 and/or petroleum wax exceed 0.5 percent by weight thereof. conforming with § 172.886 for use as pro- (d) To assure safe use of the additive: tective coatings on raw fruits and vege- (1) The label and labeling of the food tables. additive and any intermediate premix (d) To assure safe use of the additive, prepared therefrom shall bear, in addi- in addition to the other information re- tion to the other information required quired by the Act: by the act, the following:

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00107 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.846 21 CFR Ch. I (4–1–11 Edition)

(i) The name of the additive. (4) As a formulation aid, processing (ii) A statement of the concentration aid, or surface-active agent in dehy- or strength of the additive in any in- drated potatoes, in an amount not to termediate premixes. exceed 0.5 percent of the dry weight of (2) The label or labeling of the food the food. additive shall also bear adequate direc- (5) As an emulsifier, stabilizer, or tions of use to provide a finished food texturizer in snack dips, at a level not that complies with the limitations pre- to exceed 0.2 percent by weight of the scribed in paragraph (c) of this section. finished product. (6) As an emulsifier, stabilizer, or § 172.846 Sodium stearoyl lactylate. texturizer in cheese substitutes and The food additive sodium stearoyl imitations and cheese product sub- lactylate (CAS Reg. No. 25–383–997) may stitutes and imitations, at a level not be safely used in food in accordance to exceed 0.2 percent by weight of the with the following prescribed condi- finished food. tions: (7) As an emulsifier, stabilizer, or (a) The additive, which is a mixture texturizer in sauces or gravies, and the of sodium salts of stearoyl lactylic products containing the same, in an acids and minor proportions of sodium amount not to exceed 0.25 percent by salts of related acids, is manufactured weight of the finished food. by the reaction of stearic acid and lac- (8) In prepared mixes for each of the tic acid and conversion to the sodium foods listed in paragraphs (c) (1) salts. through (7) of this section, provided the (b) The additive meets the specifica- additive is used only as specified in tions of the ‘‘Food Chemicals Codex,’’ each of those paragraphs. 3d Ed. (1981), pp. 300–301, which is incor- (9) As an emulsifier, stabilizer, or porated by reference. Copies may be texturizer in cream liqueur drinks, at a obtained from the National Academy level not to exceed 0.5 percent by Press, 2101 Constitution Ave. NW., weight of the finished product. Washington, DC 20418, or may be exam- [45 FR 51767, Aug. 5, 1980, as amended at 49 ined at the National Archives and FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, Records Administration (NARA). For 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. information on the availability of this 27, 1986; 65 FR 60859, Oct. 13, 2000] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 172.848 Lactylic esters of fatty acids. federallregister/ Lactylic esters of fatty acids may be codeloflfederallregulations/ safely used in food in accordance with ibrllocations.html. the following prescribed conditions: (c) It is used or intended for use as (a) They are prepared from lactic follows when standards of identity es- acid and fatty acids meeting the re- tablished under section 401 of the Act quirements of § 172.860(b) and/or oleic do not preclude such use: acid derived from tall oil fatty acids (1) As a dough strengthener, emulsi- meeting the requirements of § 172.862. fier, or processing aid in baked prod- (b) They are used as emulsifiers, plas- ucts, pancakes, and waffles, in an ticizers, or surface-active agents in the amount not to exceed 0.5 part for each following foods, when standards of 100 parts by weight of flour used. identity do not preclude their use: (2) As a surface-active agent, emulsi- Foods Limitations fier, or stabilizer in icings, fillings, puddings, and toppings, at a level not Bakery mixes ...... to exceed 0.2 percent by weight of the Baked products ...... Cake icings, fillings, and toppings finished food. Dehydrated fruits and vegetables (3) As an emulsifier or stabilizer in Dehydrated fruit and vegetable liquid and solid edible fat-water emul- juices. Edible vegetable fat-water emul- As substitutes for milk or sions intended for use as substitutes sions. cream in beverage cof- for milk or cream in beverage coffee, at fee. a level not to exceed 0.3 percent by Frozen desserts ...... Liquid shortening ...... For household use. weight of the finished edible fat-water Pancake mixes ...... emulsion. Precooked instant rice ......

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00108 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.858

Foods Limitations (a) They are prepared from corn oil, cottonseed oil, lard, palm oil from Pudding mixes ...... fruit, peanut oil, safflower oil, sesame oil, soybean oil, and tallow and the (c) They are used in an amount not fatty acids derived from these sub- greater than required to produce the stances (hydrogenated and nonhydro- intended physical or technical effect, genated) meeting the requirements of and they may be used with shortening § 172.860(b) and/or oleic acid derived and edible fats and oils when such are from tall oil fatty acids meeting the required in the foods identified in para- requirements of § 172.862. graph (b) of this section. (b) They are used as emulsifiers in § 172.850 Lactylated fatty acid esters food, in amounts not greater than that of glycerol and propylene glycol. required to produce the intended physical or technical effect. The food additive lactylated fatty (c) Polyglycerol esters of a mixture acid esters of glycerol and propylene of stearic, oleic, and coconut fatty glycol may be safely used in food in ac- acids are used as a cloud inhibitor in cordance with the following prescribed vegetable and salad oils when use is conditions: not precluded by standards of identity. (a) The additive is a mixture of esters The fatty acids used in the production produced by the lactylation of a prod- of the polyglycerol esters meet the re- uct obtained by reacting edible fats or quirements of § 172.860(b), and the oils with propylene glycol. polyglycerol esters are used at a level (b) The additive meets the following not in excess of the amount required to specifications: Water insoluble com- perform its cloud-inhibiting effect. bined lactic acid, 14–18 percent; and Oleic acid derived from tall oil fatty acid number, 12 maximum. acids conforming with § 172.862 may be (c) It is used in amounts not in excess used as a substitute for or together of that reasonably required to produce with the oleic acid permitted by this the intended physical effect as an paragraph. emulsifier, plasticizer, or surface-ac- (d) Polyglycerol esters of butter oil tive agent in food. fatty acids are used as emulsifiers in combination with other approved emul- § 172.852 Glyceryl-lacto esters of fatty sifiers in dry, whipped topping base. acids. The fatty acids used in the production Glyceryl-lacto esters of fatty acids of the polyglycerol esters meet the re- (the lactic acid esters of mono- and quirements of § 172.860(b), and the diglycerides) may be safely used in polyglycerol esters are used at a level food in accordance with the following not in excess of the amount required to prescribed conditions: perform their emulsifying effect. (a) They are manufactured from glycerin, lactic acid, and fatty acids con- § 172.856 Propylene glycol mono- and forming with § 172.860 and/or oleic acid diesters of fats and fatty acids. derived from tall oil fatty acids con- Propylene glycol mono- and diesters forming with § 172.862 and/or edible fats of fats and fatty acids may be safely and oils. used in food, subject to the following (b) They are used in amounts not in prescribed conditions: excess of those reasonably required to (a) They are produced from edible accomplish their intended physical or fats and/or fatty acids in compliance technical effect as emulsifiers and plas- with § 172.860 and/or oleic acid derived ticizers in food. from tall oil fatty acids in compliance with § 172.862. § 172.854 Polyglycerol esters of fatty (b) They are used in food in amounts acids. not in excess of that reasonably re- Polyglycerol esters of fatty acids, up quired to produce their intended effect. to and including the decaglycerol esters, may be safely used in food in ac- § 172.858 Propylene glycol alginate. cordance with the following prescribed The food additive propylene glycol conditions: alginate (CAS Reg. No. 9005–37–2) may

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00109 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.859 21 CFR Ch. I (4–1–11 Edition)

be used as an emulsifier, flavoring ad- at a level not to exceed 0.6 percent by juvant, formulation aid, stabilizer, sur- weight of the finished product. factant, or thickener in foods in ac- (9) As a flavoring adjunct or adjuvant cordance with the following prescribed in seasonings and flavors at a level not conditions: to exceed 1.7 percent by weight of the (a) The additive meets the specifica- finished product. tions of the Food Chemicals Codex, 3d (10) As an emulsifier, flavoring adju- Ed. (1981), p. 256, which is incorporated vant, formulation aid, stabilizer or by reference (Copies are available from thickener, or surface active agent in the National Academy Press, 2101 Con- other foods, where applicable, at a stitution Ave. NW., Washington, DC level not to exceed 0.3 percent by 20418, or available for inspection at the weight of the finished product. National Archives and Records Admin- (c) To ensure safe use of the additive, istration (NARA). For information on the label of the food additive container the availability of this material at shall bear, in addition to the other in- NARA, call 202–741–6030, or go to: http:// formation required by the act: www.archives.gov/federallregister/ (1) The name of the additive, ‘‘pro- codeloflfederallregulations/ pylene glycol alginate’’ or ‘‘propylene ibrllocations.html.), and the additional glycol ester of alginic acid’’. specification that it shall have up to 85 (2) Adequate directions for use. percent of the carboxylic acid groups [47 FR 29950, July 9, 1982] esterified with the remaining groups either free or neutralized. § 172.859 Sucrose fatty acid esters. (b) The additive is used or intended Sucrose fatty acid esters identified in for use in the following foods as defined this section may be safely used in ac- in § 170.3(n) of this chapter, when stand- cordance with the following prescribed ards of identity established under sec- conditions: tion 401 of the act do not preclude such (a) Sucrose fatty acid esters are the use: mono-, di-, and tri-esters of sucrose (1) As a stabilizer in frozen dairy des- with fatty acids and are derived from serts, in fruit and water ices, and in sucrose and edible tallow or hydro- confections and frostings at a level not genated edible tallow or edible vege- to exceed 0.5 percent by weight of the table oils. The only solvents which finished product. may be used in the preparation of su- (2) As an emulsifier, flavoring adju- crose fatty acid esters are those gen- vant, stabilizer, or thickener in baked erally recognized as safe in food or reg- goods at a level not to exceed 0.5 per- ulated for such use by an appropriate cent by weight of the finished product. section in this part. Ethyl acetate or (3) As an emulsifier, stabilizer, or methyl ethyl ketone or dimethyl sulf- thickener in cheeses at a level not to oxide and isobutyl alcohol (2-methyl-1- exceed 0.9 percent by weight of the fin- propanol) may be used in the prepara- ished product. tion of sucrose fatty acid esters. (4) As an emulsifier, stabilizer, or (b) Sucrose fatty acid esters meet the thickener in fats and oils at a level not following specifications: to exceed 1.1 percent by weight of the (1) The total content of mono-, di-, finished product. and tri-esters is not less than 80 per- (5) As an emulsifier, stabilizer, or cent as determined by a method title thickener in gelatins and puddings at a ‘‘Sucrose Fatty Acid Esters, Method of level not to exceed 0.6 percent by Assay,’’ which is incorporated by ref- weight of the finished product. erence. Copies are available from the (6) As a stabilizer or thickener in gra- Center for Food Safety and Applied Nu- vies and in sweet sauces at a level not trition (HFS–200), Food and Drug Ad- to exceed 0.5 percent by weight of the ministration, 5100 Paint Branch Pkwy., finished product. College Park, MD 20740, or available for (7) As a stabilizer in jams and jellies inspection at the National Archives at a level not to exceed 0.4 percent by and Records Administration (NARA). weight of the finished product. For information on the availability of (8) As an emulsifier, stabilizer, or this material at NARA, call 202–741– thickener in condiments and relishes 6030, or go to: http://www.archives.gov/

100

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00110 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.859

federallregister/ tled ‘‘Determination of Dimethyl Sulf- codeloflfederallregulations/ oxide,’’ which is incorporated by ref- ibrllocations.html. erence. Copies are available from the (2) The free sucrose content is not Center for Food Safety and Applied Nu- more than 5 percent as determined by trition (HFS–200), Food and Drug Ad- Test S.2 in the method titled ‘‘Sucrose ministration, 5100 Paint Branch Pkwy., Fatty Acid Esters, Method of Assay,’’ College Park, MD 20740, or available for which is incorporated by reference. The inspection at the National Archives availability of this incorporation by and Records Administration (NARA). reference is given in paragraph (b)(1) of For information on the availability of this section. this material at NARA, call 202–741– (3) The acid value is not more than 6. 6030, or go to: http://www.archives.gov/ (4) The residue on ignition (sulfated federallregister/ ash) is not more than 2 percent. codeloflfederallregulations/ (5) The total ethyl acetate content is ibrllocations.html. not more than 350 parts per million as (11) The total isobuytl alcohol (2- determined by a method titled ‘‘Deter- methyl-1-propanol) content is not more mination of Ethyl Acetate,’’ which is than 10 parts per million as determined incorporated by reference. Copies are by a method entitled ‘‘Determination available from the Center for Food of Isobutyl Alcohol,’’ which is incor- Safety and Applied Nutrition (HFS– porated by reference. Copies are avail- 200), Food and Drug Administration, able from the Center for Food Safety 5100 Paint Branch Pkwy., College Park, and Applied Nutrition (HFS–200), Food MD 20740, or available for inspection at and Drug Administration, 5100 Paint the National Archives and Records Ad- Branch Pkwy., College Park, MD 20740, ministration (NARA). For information or available for inspection at the Na- on the availability of this material at tional Archives and Records Adminis- NARA, call 202–741–6030, or go to: http:// tration (NARA). For information on www.archives.gov/federallregister/ the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http:// ibrllocations.html. www.archives.gov/federallregister/ (6) Arsenic is not more than 3 parts codeloflfederallregulations/ per million. ibrllocations.html. (7) Total heavy metal content (as Pb) (c) Sucrose fatty acid esters may be is not more than 50 parts per million. used as follows when standards of iden- (8) Lead is not more than 10 parts per tity established under section 401 of million. the Federal Food, Drug, and Cosmetic (9) The total content of methyl ethyl Act do not preclude such use: ketone or of methanol shall not be (1) As emulsifiers as defined in more than 10 parts per million as deter- § 170.3(o)(8) of this chapter, or as stabi- mined by a method titled ‘‘Methyl lizers as defined in § 170.3(o)(28) of this Ethyl Ketone Test; Methyl Alcohol chapter, in baked goods and baking Test,’’ which is incorporated by ref- mixes as defined in § 170.3(n)(1) of this erence. Copies are available from the chapter, in chewing gum as defined in Center for Food Safety and Applied Nu- § 170.3(n)(6) of this chapter, in coffee trition (HFS–200), Food and Drug Ad- and tea beverages with added dairy in- ministration, 5100 Paint Branch Pkwy., gredients and/or dairy product ana- College Park, MD 20740, or available for logues, in confections and frostings as inspection at the National Archives defined in § 170.3(n)(9) of this chapter, and Records Administration (NARA). in dairy product analogues as defined For information on the availability of in § 170.3(n)(10) of this chapter, in frozen this material at NARA, call 202–741– dairy desserts and mixes as defined in 6030, or go to: http://www.archives.gov/ § 170.3(n)(20) of this chapter, and in federallregister/ whipped milk products. codeloflfederallregulations/ (2) As texturizers as defined in ibrllocations.html. § 170.3(o)(32) of this chapter in biscuit (10) The total dimethyl sulfoxide con- mixes, in chewing gum as defined in tent is not more than 2 parts per mil- § 170.3(n)(6) of this chapter, in confec- lion as determined by a method enti- tions and frostings as defined in

101

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00111 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.860 21 CFR Ch. I (4–1–11 Edition)

§ 170.3(n)(9) of this chapter, and in the 13th Ed. (1980) of the ‘‘Official surimi-based fabricated seafood prod- Methods of Analysis of the Association ucts. of Official Analytical Chemists,’’ which (3) As components of protective coat- is incorporated by reference. Copies are ings applied to fresh apples, avocados, available from the AOAC INTER- bananas, banana plantains, limes, mel- NATIONAL, 481 North Frederick Ave., ons (honeydew and cantaloupe), pa- suite 500, Gaithersburg, MD 20877, or paya, peaches, pears, pineapples, and available for inspection at the National plums to retard ripening and spoiling. Archives and Records Administration (d) Sucrose fatty acid esters are used (NARA). For information on the avail- in accordance with current good manu- ability of this material at NARA, call facturing practice and in an amount 202–741–6030, or go to: http:// not to exceed that reasonably required www.archives.gov/federallregister/ to accomplish the intended effect. codeloflfederallregulations/ [47 FR 55475, Dec. 10, 1982, as amended at 48 ibrllocations.html. FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, (2) Chick-edema factor shall be deter- 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR mined by the bioassay method de- 24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995] scribed in ‘‘Official Methods of Anal- ysis of the Association of Official Ana- § 172.860 Fatty acids. lytical Chemists,’’ 13th Ed. (1980), sec- The food additive fatty acids may be tions 28.127–28.130, which is incor- safely used in food and in the manufac- porated by reference. Copies may be ture of food components in accordance obtained from the AOAC INTER- with the following prescribed condi- NATIONAL, 481 North Frederick Ave., tions: suite 500, Gaithersburg, MD 20877, or (a) The food additive consists of one may be examined at the National Ar- or any mixture of the following chives and Records Administration straight-chain monobasic carboxylic (NARA). For information on the avail- acids and their associated fatty acids ability of this material at NARA, call manufactured from fats and oils de- 202–741–6030, or go to: http:// rived from edible sources: Capric acid, www.archives.gov/federallregister/ caprylic acid, lauric acid, myristic codeloflfederallregulations/ acid, oleic acid, palmitic acid, and ste- ibrllocations.html. aric acid. (3) The gas chromatographic-electron (b) The food additive meets the fol- capture method for testing fatty acids lowing specifications: for chick-edema shall be the method (1) Unsaponifiable matter does not described in the ‘‘Journal of the Asso- exceed 2 percent. ciation of Official Analytical Chem- (2) It is free of chick-edema factor: ists,’’ Volume 50 (No. 1), pages 216–218 (i) As evidenced during the bioassay method for determining the chick- (1967), or the modified method using a edema factor as prescribed in para- sulfuric acid clean-up procedure, as de- graph (c)(2) of this section; or scribed in the ‘‘Journal of the Associa- (ii) As evidenced by the absence of tion of the Offical Analytical Chem- chromatographic peaks with a reten- ists,’’ Volume 51 (No. 2), pages 489–490 tion time relative to aldrin (RA) be- (1968), which are incorporated by ref- tween 10 and 25, using the gas erence. See paragraph (c)(2) of this sec- chromatographic-electron capture tion for availability of these ref- method prescribed in paragraph (c)(3) erences. of this section. If chromatographic (d) It is used or intended for use as peaks are found with RA values be- follows: tween 10 and 25, the food additive shall (1) In foods as a lubricant, binder, meet the requirements of the bioassay and as a defoaming agent in accordance method prescribed in paragraph (c)(2) with good manufacturing practice. of this section for determining chick- (2) As a component in the manufac- edema factor. ture of other food-grade additives. (c) For the purposes of this section: (e) To assure safe use of the additive, (1) Unsaponifiable matter shall be de- the label and labeling of the additive termined by the method described in and any premix thereof shall bear, in

102

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00112 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.862

addition to the other information re- used in food and as a component in the quired by the act, the following: manufacture of food-grade additives in (1) The common or usual name of the accordance with the following pre- acid or acids contained therein. scribed conditions: (2) The words ‘‘food grade,’’ in jux- (a) The additive consists of purified taposition with and equally as promi- oleic acid separated from refined tall nent as the name of the acid. oil fatty acids. [42 FR 14491, Mar. 15, 1977, as amended at 47 (b) The additive meets the following FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, specifications: 1984; 54 FR 24897, June 12, 1989] (1) Specifications for oleic acid prescribed in the ‘‘Food Chemicals § 172.861 Cocoa butter substitute from Codex.’’ 3d Ed. (1981), pp. 207–208, which coconut oil, palm kernel oil, or both is incorporated by reference, except oils. that titer (solidification point) shall The food additive, cocoa butter sub- not exceed 13.5 °C and unsaponifiable stitute from coconut oil, palm kernel matter shall not exceed 0.5 percent. oil, or both oils, may be safely used in Copies of the material incorporated by food in accordance with the following reference may be obtained from the conditions: National Academy Press, 2101 Constitu- (a) Cocoa butter substitute from co- tion Ave. NW., Washington, DC 20418, conut oil, palm kernel oil (CAS Reg. or may be examined at the National No. 85665–33–4), or both oils is a mixture Archives and Records Administration of triglycerides. It is manufactured by (NARA). For information on the avail- esterification of glycerol with food- ability of this material at NARA, call grade fatty acids (complying with 202–741–6030, or go to: http:// § 172.860) derived from edible coconut www.archives.gov/federallregister/ oil, edible palm kernel oil, or both oils. codeloflfederallregulations/ (b) The ingredient meets the fol- ibrllocations.html. lowing specifications: (2) The resin acid content does not Acid number: Not to exceed 0.5. exceed 0.01 as determined by ASTM Saponification number: 220 to 260. method D1240–82, ‘‘Standard Test Meth- Iodine number: Not to exceed 3. od for Rosin Acids in Fatty Acids,’’ Melting range: 30 to 44 °C. which is incorporated by reference. (c) The ingredient is used or intended Copies may be obtained from the Amer- for use as follows: ican Society for Testing Materials, 100 (1) As coating material for sugar, Barr Harbor Dr., West Conshohocken, table salt, vitamins, citric acid, suc- Philadelphia, PA 19428-2959, or may be cinic acid, and spices; and examined at the National Archives and (2) In compound coatings, cocoa Records Administration (NARA). For creams, cocoa-based sweets, toffees, information on the availability of this caramel masses, and chewing sweets as material at NARA, call 202–741–6030, or defined in § 170.3 (n)(9) and (n)(38) of go to: http://www.archives.gov/ this chapter, except that the ingredient federallregister/ may not be used in a standardized food codeloflfederallregulations/ unless permitted by the standard of ibrllocations.html. identity. (3) The requirements for absence of (d) The ingredient is used in accord- chick-edema factor as prescribed in ance with current good manufacturing § 172.860. practice and in an amount not to ex- (c) It is used or intended for use as ceed that reasonably required to ac- follows: complish the intended effect. (1) In foods as a lubricant, binder, [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, and defoaming agent in accordance 1992] with good manufacturing practice. (2) As a component in the manufac- § 172.862 Oleic acid derived from tall ture of other food-grade additives. oil fatty acids. (d) To assure safe use of the additive, The food additive oleic acid derived the label and labeling of the additive from tall oil fatty acids may be safely and any premix thereof shall bear, in

103

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00113 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.863 21 CFR Ch. I (4–1–11 Edition)

addition to the other information re- (i) Hexyl, octyl, decyl, lauryl, and quired by the Act, the following: myristyl alcohols contain not less than (1) The common or usual name of the 99 percent of total alcohols and not less acid. than 96 percent of straight chain alco- (2) The words ‘‘food grade’’ in jux- hols. Any nonalcoholic impurities are taposition with and equally as promi- primarily paraffins. nent as the name of the acid. (ii) Cetyl and stearyl alcohols con- [42 FR 14491, Mar. 15, 1977, as amended at 49 tain not less than 98 percent of total FR 10105, Mar. 19, 1984] alcohols and not less than 94 percent of straight chain alcohols. Any non- § 172.863 Salts of fatty acids. alcoholic impurities are primarily The food additive salts of fatty acids paraffins. may be safely used in food and in the (iii) The synthetic fatty alcohols con- manufacture of food components in ac- tain no more than 0.1 weight percent of cordance with the following prescribed total diols as determined by a method conditions: available upon request from the Com- (a) The additive consists of one or missioner of Food and Drugs. any mixture of two or more of the alu- (2) Hexyl, octyl, and decyl; manufac- minum, calcium, magnesium, potas- tured by fractional distillation of alco- sium, and sodium salts of the fatty hols obtained by a sequence of oxida- acids conforming with § 172.860 and/or tion, hydrolysis, and catalytic hydro- oleic acid derived from tall oil fatty genation (catalyst consists of copper, acids conforming with § 172.862. chromium, and nickel) of organo-alu- (b) The food additive is used or in- minums generated by the controlled re- tended for use as a binder, emulsifier, action of low molecular weight and anticaking agent in food in accord- trialkylaluminum with purified ethyl- ance with good manufacturing prac- ene (minimum 99 percent by volume tice. C H ), and utilizing an external coolant (c) To assure safe use of the additive, 2 4 such that these alcohols meet the spec- the label and labeling of the additive and any premix thereof shall bear, in ifications prescribed in paragraph (a)(1) addition to the other information re- (i) and (iii) of this section. quired by the Act, the following: (3) n-Octyl; manufactured by the (1) The common or usual name of the hydrodimerization of 1,3-butadiene, fol- fatty acid salt or salts contained there- lowed by catalytic hydrogenation of in. the resulting dienol, and distillation to (2) The words ‘‘food grade,’’ in jux- produce n-octyl alcohol with a min- taposition with and equally as promi- imum purity of 99 percent. The analyt- nent as the name of the salt. ical method for n-octyl alcohol entitled ‘‘Test Method [Normal-octanol]’’ dated § 172.864 Synthetic fatty alcohols. October 2003, and printed by Kuraray Synthetic fatty alcohols may be safe- Co., Ltd., is incorporated by reference. ly used in food and in the synthesis of The Director of the Office of the Fed- food components in accordance with eral Register approves this incorpora- the following prescribed conditions: tion by reference in accordance with 5 (a) The food additive consists of any U.S.C. 552(a) and 1 CFR part 51. You one of the following fatty alcohols: may obtain a copy from the Office of (1) Hexyl, octyl, decyl, lauryl, Food Additive Safety, 5100 Paint myristyl, cetyl, and stearyl; manufac- Branch Pkwy., College Park, MD 20740, tured by fractional distillation of alco- or you may examine a copy at the Cen- hols obtained by a sequence of oxida- ter for Food Safety and Applied Nutri- tion and hydrolysis of organo-alu- tion’s Library, Food and Drug Admin- minums generated by the controlled re- istration, 5100 Paint Branch Pkwy., action of low molecular weight College Park, MD 20740, or at the Na- trialkylaluminum with purified ethyl- tional Archives and Records Adminis- ene (minimum 99 percent by volume tration (NARA). For information on C2H4), and utilizing the hydrocarbon the availability of this material at solvent as defined in paragraph (b) of NARA, call 202–741–6030, or go to http:// this section, such that: www.archives.gov/federallregister/

104

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00114 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.864

codeloflfederallregulations/ vent samples in handling and to assure ab- ibrllocations.html. sence of any extraneous material arising (b) The hydrocarbon solvent used in from inadequate packaging is essential. Be- the process described in paragraph cause some of the polynuclear hydrocarbons sought in this test are very susceptible to (a)(1) of this section is a mixture of liq- photo-oxidation, the entire procedure is to uid hydrocarbons essentially paraffinic be carried out under subdued light. in nature, derived from petroleum and refined to meet the specifications de- APPARATUS scribed in paragraph (b)(1) of this sec- Chromatographic tube. 450 millimeters in tion when subjected to the procedures length (packing section), inside diameter 19 described in paragraph (b) (2) and (3) of millimeters ±1 millimeter, equipped with a this section. wad of clean Pyrex brand filtering wool (Cor- (1) The hydrocarbon solvent meets ning Glass Works Catalog No. 3950 or equivalent). The tube shall contain a 250-milliliter the following specifications: reservoir and a 2-millimeter tetrafluoro- (i) Boiling-point range: 175 °C–275 °C. ethylene polymer stopcock at the opposite (ii) Ultraviolet absorbance limits as end. Overall length of the tube is 670 milli- follows: meters. Stainless steel rod. 2 feet in length, 2 to 4 Maximum millimeters in diameter. absorbance per Vacuum oven. Similar to Labline No. 3610 Wavelength (millicrons) centimeter but modified as follows: A copper tube one- optical fourth inch in diameter and 13 inches in path length length is bent to a right angle at the 4-inch 280–289 ...... 0.15 point and plugged at the opposite end; eight 290–299 ...... 12 copper tubes one-eighth inch in diameter and 300–359 ...... 05 5 inches in length are silver soldered in 360–400 ...... 02 drilled holes (one-eighth inch in diameter) to the one-fourth-inch tube, one on each side at (2) Use ASTM method D86–82, the 5-, 7.5-, 10- and 12.5-inch points; the one- ‘‘Standard Method for Distillation of eighth-inch copper tubes are bent to conform Petroleum Products,’’ which is incor- with the inner periphery of the oven. porated by reference, to determine Beakers. 250-milliliter and 500-milliliter capacity. boiling point range. Copies of the ma- Graduated cylinders. 25-milliliter, 50-milli- terial incorporated by reference may liter, and 150-milliliter capacity. be obtained from the American Society Tuberculin syringe. 1-milliliter capacity, for Testing Materials, 100 Barr Harbor with 3-inch, 22-gauge needle. Dr., West Conshohocken, Philadelphia, Volumetric flask. 5-milliliter capacity. PA 19428-2959, or may be examined at Spectrophotometric cells. Fused quartz the National Archives and Records Ad- ground glass stoppered cells, optical path length in the range of 1.000 centimeter ±0.005 ministration (NARA). For information centimeter. With distilled water in the cells, on the availability of this material at determine any absorbance difference. NARA, call 202–741–6030, or go to: http:// Spectrophotometer. Spectral range 250 milli- www.archives.gov/federallregister/ microns—400 millimicrons with spectral slit codeloflfederallregulations/ width of 2 millimicrons or less: under instru- ibrllocations.html. ment operating conditions for these absorb- (3) The analytical method for deter- ance measurements, the spectrophotometer mining ultraviolet absorbance limits is shall also meet the following performance requirements: as follows: Absorbance repeatability, ±0.01 at 0.4 absorbance. GENERAL INSTRUCTIONS Absorbance accuracy, 1 ±0.05 at 0.4 absorb- All glassware should be scrupulously ance. cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine 1 As determined by using potassium chro- all glassware, including stoppers and stop- mate for reference standard and described in cocks, under ultraviolet light to detect any National Bureau of Standards Circular 484, residual fluorescent contamination. As a pre- Spectrophotometry, U.S. Department of cautionary measure, it is recommended prac- Commerce, (1949). The accuracy is to be de- tice to rinse all glassware with purified iso- termined by comparison with the standard octane immediately before use. No grease is values at 290, 345, and 400 millimicrons. Cir- to be used on stopcocks or joints. Great care cular 484 is incorporated by reference. Copies to avoid contamination of hydrocarbon sol- Continued

105

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00115 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.864 21 CFR Ch. I (4–1–11 Edition)

Wavelength repeatability, ±0.2 milli- equivalent). Use 20 milliliters for test. If nec- micron. essary, 1,2-dichloroethane may be purified by Wavelength accuracy, ±1.0 millimicron. distillation. Nitrogen cylinder. Water-pumped or equiva- Eluting mixtures: lent purity nitrogen in cylinder equipped 1. 10 percent 1,2-dichloroethane in hexane. with regulator and valve to control flow at 5 Pipet 100 milliliters of 1,2-dichloroethane p.s.i.g. into a 1-liter glass-stoppered volumetric flask and adjust to volume with hexane, with REAGENTS AND MATERIALS mixing. Organic solvents. All solvents used through- 2. 40 percent benzene in hexane. Pipet 400 out the procedure shall meet the specifica- milliliters of benzene into a 1-liter glass- tions and tests described in this specifica- stoppered volumetric flask and adjust to vol- tion. The isooctane, benzene, hexane, and 1,2- ume with hexane, with mixing. dichloroethane designated in the list fol- n-Hexadecane, 99 percent olefin-free. Dilute lowing this paragraph shall pass the fol- 1.0 milliliter of n-hexadecane to 5 milliliters lowing test: with isooctane and determine the absorbance To the specified quantity of solvent in a in a 1-centimeter cell compared to isooctane 250-milliliter beaker, add 1 milliliter of puri- as reference between 280 mμ-400mμ. The ab- fied n-hexadecane and evaporate in the vacu- sorbance per centimeter path length shall um oven under a stream of nitrogen. Dis- not exceed 0.00 in this range. If necessary, n- continue evaporation when not over 1 milli- hexadecane may be purified by percolation liter of residue remains. (To the residue from through activated silica gel or by distilla- benzene add a 5-milliliter portion of purified tion. isooctane, reevaporate, and repeat once to Silica gel, 28–200 mesh (Grade 12, Davison insure complete removal of benzene.) Chemical Co., Baltimore, Md., or equivalent). Dissolve the 1 milliliter of hexadecane res- Activate as follows: Weigh about 900 grams idue in isooctane and make to 5 milliliters into a 1-gallon bottle, add 100 milliliters of volume. Determine the absorbance in the 1- de-ionized water, seal the bottle and shake centimeter path length cells compared to and roll at intervals for 1 hour. Allow to isooctane as reference. The absorbance of the equilibrate overnight in the sealed bottle. solution of the solvent residue shall not ex- Activate the gel at 150 °C for 16 hours, in a ceed 0.02 per centimeter path length between 2-inch × 7-inch × 12-inch porcelain pan loose- 280 and 300 mμ and shall not exceed 0.01 per ly covered with aluminum foil, cool in a centimeter path length between 300 and 400 dessicator, transfer to a bottle and seal. mμ. Isooctane (2,2,4-trimethylpentane). Use 10 PROCEDURE milliliters for the test described in the pre- Determination of ultraviolet absorbance. Be- ceding paragraph. If necessary, isooctane fore proceeding with the analysis of a sample may be purified by passage through a column determine the absorbance in a 1-centimeter of activated silica gel (Grade 12, Davison path cell for the reagent blank by carrying Chemical Co., Baltimore, Md., or equiva- out the procedure without a sample. Record lent). the absorbance in the wavelength range of Benzene, spectro grade (Burdick and Jackson 280 to 400 millimicrons. Typical reagent Laboratories, Inc., Muskegon, Mich., or equiva- blank absorbance in this range should not lent). Use 80 milliliters for the test. If nec- exceed 0.04 in the 280 to 299 millimicron essary, benzene may be purified by distilla- range, 0.02 in the 300 to 359 millimicron tion or otherwise. range, and 0.01 in the 360 to 400 millimicron Hexane, spectro grade (Burdick and Jackson range. If the characteristic benzene peaks in Laboratories, Inc., Muskegon, Mich., or equiva- the 250 to 260 millimicron region are present, lent). Use 650 milliliters for the test. If nec- remove the benzene by the procedure de- essary, hexane may be purified by distilla- scribed above under ‘‘Reagents and Mate- tion or otherwise. rials,’’ ‘‘Organic Solvents,’’ and record ab- 1,2-Dichloroethane, spectro grade (Matheson, sorbance again. Coleman, and Bell, East Rutherford, N.J., or Transfer 50 grams of silica gel to the chromatographic tube for sample analysis. are available from the Center for Food Safe- Raise and drop the column on a semisoft, ty and Applied Nutrition (HFS–200), Food clean surface for about 1 minute to settle the and Drug Administration, 5100 Paint Branch gel. Pour 100 milliliters of hexane into the Pkwy., College Park, MD 20740, or available column with the stopcock open and allow to for inspection at the National Archives and drain to about one-half inch above the gel. Records Administration (NARA). For infor- Turn off the stopcock and allow the column mation on the availability of this material to cool for 30 minutes. After cooling, vibrate at NARA, call 202–741–6030, or go to: http:// the column to eliminate air and stir the top www.archives.gov/federallregister/ 1 to 2 inches with a small diameter stainless codeloflfederallregulations/ steel rod. Take care not to get the gel above ibrllocations.html. the liquid and onto the sides of the column.

106

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00116 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.867

Weigh out 40 grams ±0.1 gram of the hydro- cohols used as intermediates in the carbon solvent sample into a 250-milliliter synthesis of food additives and other beaker, add 50 milliliters of hexane, and pour substances permitted in food. the solution into the column. Rinse the beaker with 50 milliliters of hexane and add [42 FR 14491, Mar. 15, 1977, as amended at 47 this to the column. Allow the hexane sample FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, solution to elute into a 500-milliliter beaker 1984; 54 FR 24897, June 12, 1989; 70 FR 72908, until the solution is about one-half inch Dec. 8, 2005] above the gel. Rinse the column three times with 50-milliliter portions of hexane. Allow § 172.866 Synthetic glycerin produced each hexane rinse to separately elute to by the hydrogenolysis of carbo- about one-half inch above the gel. Replace hydrates. the eluate beaker (discard the hexane eluate) with a 250-milliliter beaker. Add two sepa- Synthetic glycerin produced by the rate 25-milliliter portions of 10 percent 1,2- hydrogenolysis of carbohydrates may dichloroethane and allow each to separately be safely used in food, subject to the elute as before. Finally, add 150 milliliters of provisions of this section: 10 percent 1,2-dichloroethane for a total of 200 milliliters. When the final 10 percent 1,2- (a) It shall contain not in excess of dichloroethane fraction is about one-half 0.2 percent by weight of a mixture of inch above the top of the gel bed, replace the butanetriols. receiving beaker (discard the 1,2- (b) It is used or intended for use in an dichloroethane eluate) with a 250-milliliter amount not to exceed that reasonably beaker containing 1 milliliter of hexadecane. required to produce its intended effect. Adjust the elution rate to 2 to 3 milliliters per minute, add two 25-milliliter portions of 40 percent benzene and allow each to sepa- § 172.867 Olestra. rately elute as before to within about one- Olestra, as identified in this section, half inch of the gel bed. Finally, add 150 mil- may be safely used in accordance with liliters of 40 percent benzene for a total of 200 milliliters. Evaporate the benzene in the the following conditions: oven with vacuum and sufficient nitrogen (a) Olestra is a mixture of octa-, flow to just ripple the top of the benzene so- hepta-, and hexa-esters of sucrose with lution. When the benzene is removed (as de- fatty acids derived from edible fats and termined by a constant volume of hexa- oils or fatty acid sources that are gen- decane) add 5 milliliters of isooctane and erally recognized as safe or approved evaporate. Repeat once to insure complete for use as food ingredients. The chain removal of benzene. Remove the beaker and cover with aluminum foil (previously rinsed lengths of the fatty acids are no less with hexane) until cool. than 12 carbon atoms. Quantitatively transfer the hexadecane (b) Olestra meets the specifications residue to a 5-milliliter volumetric flask and of the Food Chemicals Codex, 4th edi- dilute to volume with isooctane. Determine tion, 1st supplement (1997), pp. 33–35, the absorbance of the solution in 1-centi- which is incorporated by reference. The meter path length cells between 280 and 400 Director of the Office of the Federal millimicrons using isooctane as a reference. Correct the absorbance values for any ab- Register approves this incorporation sorbance derived from reagents as deter- by reference in accordance with 5 mined by carrying out the procedure without U.S.C. 552(a) and 1 CFR part 51. You a sample. If the corrected absorbance does may obtain copies from the National not exceed the limits prescribed in para- Academy Press, 2101 Constitution Ave. graph (b)(1)(ii) of this section, the sample NW., Washington, DC 20418 (Internet meets the ultraviolet absorbance specifica- address http://www.nap.edu). Copies tions for hydrocarbon solvent. may be examined at the Center for (c) Synthetic fatty alcohols may be Food Safety and Applied Nutrition’s used as follows: Library, Food and Drug Administra- (1) As substitutes for the cor- tion, 5100 Paint Branch Pkwy., College responding naturally derived fatty al- Park, MD 20740, or at the National Ar- cohols permitted in food by existing chives and Records Administration regulations in this part or part 173 of (NARA). For information on the avail- this chapter provided that the use is in ability of this material at NARA, call compliance with any prescribed limita- 202–741–6030, or go to: http:// tions. www.archives.gov/federallregister/ (2) As substitutes for the cor- codeloflfederallregulations/ responding naturally derived fatty al- ibrllocations.html.

107

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00117 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.868 21 CFR Ch. I (4–1–11 Edition)

(c) Olestra may be used in place of taining on an anhydrous basis not more fats and oils in prepackaged ready-to- than 2.6 ethoxy groups per eat savory (i.e., salty or piquant but anhydroglucose unit. not sweet) snacks and prepackaged, (b) It is used or intended for use as unpopped popcorn kernels that are follows: ready-to-heat. In such foods, the addi- (1) As a binder and filler in dry vita- tive may be used in place of fats and min preparations. oils for frying or baking, in dough con- (2) As a component of protective ditioners, in sprays, in filling ingredi- coatings for vitamin and mineral tab- ents, or in flavors. lets. (d) To compensate for any inter- (3) As a fixative in flavoring com- ference with absorption of fat soluble pounds. vitamins, the following vitamins shall be added to foods containing olestra: § 172.869 Sucrose oligoesters. 1.9 milligrams alpha-tocopherol equivalents per gram olestra; 51 retinol Sucrose oligoesters, as identified in equivalents per gram olestra (as this section, may be safely used in ac- retinyl acetate or retinyl palmitate); 12 cordance with the following conditions: IU vitamin D per gram olestra; and 8 μg (a) Sucrose oligoesters consist of vitamin K1 per gram olestra. mixtures of sucrose fatty acid esters (e)(1) Vitamins A, D, E, and K present with an average degree of in foods as a result of the requirement esterification ranging from four to in paragraph (d) of this section shall be seven. It is produced by declared in the listing of ingredients. interesterification of sucrose with Such vitamins shall not be considered methyl esters of fatty acids derived in determining nutrient content for the from edible fats and oils (including hy- nutritional label or for any nutrient drogenated fats and oils). The only sol- claims, express or implied. vents which may be used in the prepa- (i) An asterisk shall follow vitamins ration of sucrose oligoesters are di- A, D, E, and K in the listing of ingredi- methyl sulfoxide, isobutyl alcohol, and ents; those solvents generally recognized as (ii) The asterisk shall appear as a su- safe in food. perscript following each vitamin; (b) Sucrose oligoesters meet the spec- (iii) Immediately following the ingre- ifications in the methods listed in the dient list an asterisk and statement, table in this paragraph. The methods ‘‘Dietarily insignificant’’ shall appear cited for determining compliance with prominently and conspicuously as spec- each specification are incorporated by ified in § 101.2(c) of this chapter; reference, in accordance with 5 U.S.C. (2) Olestra shall not be considered as 552(a) and 1 CFR part 51. Copies of the a source of fat or calories for purposes methods may be examined at the Cen- of §§ 101.9 and 101.13 of this chapter. ter for Food Safety and Applied Nutri- [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, tion’s Library, room 1C–100, 5100 Paint 1996, as amended at 68 FR 46402, Aug. 5, 2003; Branch Pkwy., College Park, MD 20740, 69 FR 29432, May 24, 2004] or at the National Archives and Records Administration (NARA). For § 172.868 Ethyl cellulose. information on the availability of this The food additive ethyl cellulose may material at NARA, call 202–741–6030, or be safely used in food in accordance go to: http://www.archives.gov/ with the following prescribed condi- federallregister/ tions: codeloflfederallregulations/ (a) The food additive is a cellulose ibrllocations.html. Copies of the meth- ether containing ethoxy (OC2H5) groups ods are available from the sources list- attached by an ether linkage and con- ed in the table in this paragraph:

108

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00118 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.870

Specification Limit Method Cited Source for Obtaining Method

(1) Sucrose esters ...... Not less than 90% ...... ‘‘Method for Analyzing the Pu- Office of Food Additive Safe- rity of Sucrose Fatty Acid ty, Center for Food Safety Esters,’’ issued by and Applied Nutrition (HFS– Mitsubishi Chemical Corp., 200), Food and Drug Ad- June 17, 1998. ministration, 5100 Paint Branch Pkwy., College Park, MD 20740.

(2) Mono-, di-, and tri-esters ... Not more than 45% ...... ‘‘Method for Measuring the Do. Ester Distribution of Su- crose Oligoesters,’’ issued by Mitsubishi Chemical Corp., June 17, 1998.

(3) Tetra-, penta-, hexa-, and Not less than 50% ...... Do. Do. hepta-esters.

(4) Octa-esters ...... Not more than 40% ...... Do. Do.

(5) Free Sucrose ...... Not more than 0.5% ...... ‘‘Free Sucrose Method,’’ Do. issued by Mitsubishi Chem- ical Corp., June 17, 1998.

(6) Acid Value ...... Not more than 4.0 ...... ‘‘Acid Value,’’ Appendix VII, National Academy Press, Method I (Commercial Fatty 2101 Constitution Ave. NW, Acids), in the Food Chemi- Washington, DC 20418 cals Codex, 4th ed. (1996), (Internet: http:// p. 820. www.nap.edu).

(7) Residue on Ignition ...... Not more than 0.7% ...... ‘‘Residue on Ignition, Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 4th ed. (1996), pp. 751–752, (using a 1-gram sample).

(8) Residual Methanol ...... Not more than 10 milligrams/ Method listed in the mono- Do. kilogram. graph for ‘‘Sucrose Fatty Acid Esters’’ in the First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44–45.

(9) Residual Dimethyl Sulf- Not more than 2.0 milligrams/ Do. Do. oxide. kilogram.

(10) Residual Isobutyl Alcohol Not more than 10 milligrams/ Do. Do. kilogram.

(11) Lead ...... Not more than 1.0 milligram/ ‘‘Atomic Absorption Do. kilogram. Spectrophotometric Graph- ite Furnace Method,’’ Meth- od I, in the Food Chemicals Codex, 4th ed. (1996), pp. 763–765.

(c) The additive is used as an emulsi- § 172.870 Hydroxypropyl cellulose. fier (as defined in § 170.3(o)(8) of this The food additive hydroxypropyl cel- chapter) or stabilizer (as defined in lulose may be safely used in food, ex- § 170.3(o)(28) of this chapter) in choco- cept standardized foods that do not late and in butter-substitute spreads, provide for such use, in accordance at a level not to exceed 2.0 percent; ex- with the following prescribed condi- cept that the additive may not be used tions: in a standardized food unless permitted (a) The additive consists of one of the by the standard of identity. following: (1) A cellulose ether containing pro- [68 FR 50072, Aug. 20, 2003] pylene glycol groups attached by an ether linkage which contains, on an anhydrous basis, not more than 4.6

109

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00119 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.872 21 CFR Ch. I (4–1–11 Edition)

hydroxypropyl groups per (3) The ash content on a dry basis has anhydroglucose unit. The additive has a maximum of 0.6 percent. a minimum viscosity of 145 centipoises (c) The food additive is used as an for 10 percent by weight aqueous solu- aerating, emulsifying, and foaming tion at 25 °C. agent, in an amount not in excess of (2) A cellulose ether containing pro- that reasonably required to produce its pylene glycol groups attached by an intended effect. ether linkage having a hydroxypropoxy (OC3H6OH) content of 5 to 16 percent § 172.874 Hydroxypropyl weight in weight (w/w) on an anhydrous methylcellulose. basis, i.e., 0.1 to 0.4 hydroxypropyl The food additive hydroxypropyl groups per anhydroglucose unit. The methylcellulose (CAS Reg. No. 9004–65– common name for this form of the ad- 3) may be safely used in food, except in ditive is low substituted hydroxypropyl standardized foods which do not pro- cellulose. vide for such use if: (b) The additive is used or intended (a) The additive complies with the for use as follows: definition and specifications prescribed (1) The additive identified in para- in the National Formulary, 12th edi- graph (a)(1) of this section is used or tion. intended for use as an emulsifier, film (b) It is used or intended for use as an former, protective colloid, stabilizer, emulsifier, film former, protective col- suspending agent, or thickener, in ac- loid, stabilizer, suspending agent, or cordance with good manufacturing thickener, in accordance with good practice. manufacturing practice. (2) The additive identified in para- (c) To insure safe use of the additive, graph (a)(2) of this section is used or the container of the additive, in addi- intended for use as a binder and dis- tion to being labeled as required by the integrator in tablets or wafers con- general provisions of the act, shall be taining dietary supplements of vita- accompanied by labeling which con- mins and/or minerals. The additive is tains adequate directions for use to used in accordance with good manufac- provide a final product that complies turing practice. with the limitations prescribed in para- [46 FR 50065, Oct. 9, 1981] graph (b) of this section. [42 FR 14491, Mar. 15, 1977, as amended at 47 § 172.872 Methyl ethyl cellulose. FR 38273, Aug. 31, 1982] The food additive methyl ethyl cellulose may be safely used in food in ac- § 172.876 Castor oil. cordance with the following prescribed The food additive castor oil may be conditions. safely used in accordance with the fol- (a) The additive is a cellulose ether lowing conditions: having the general formula (a) The additive meets the specifica- [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is tions of the United States Pharma- the number of methyl groups and y is copeia XX (1980). the number of ethyl groups. The aver- (b) The additive is used or intended age value of x is 0.3 and the average for use as follows: value of y is 0.7. (b) The additive meets the following Use and Limitations specifications: Hard candy production—As a release agent (1) The methoxy content shall be not and antisticking agent, not to exceed 500 less than 3.5 percent and not more than parts per million in hard candy. Vitamin and mineral tablets—As a compo- 6.5 percent, calculated as OCH3, and the ethoxy content shall be not less than nent of protective coatings. 14.5 percent and not more than 19 per- [42 FR 14491, Mar. 15, 1977, as amended at 49 cent, calculated as OC2H5, both meas- FR 10105, Mar. 19, 1984] ured on the dry sample. (2) The viscosity of an aqueous solu- § 172.878 White mineral oil. tion, 2.5 grams of the material in 100 White mineral oil may be safely used milliliters of water, at 20 °C, is 20 to 60 in food in accordance with the fol- centipoises. lowing conditions:

110

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00120 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.878

(a) White mineral oil is a mixture of the Center for Food Safety and Applied liquid hydrocarbons, essentially par- Nutrition (HFS–200), Food and Drug affinic and naphthenic in nature ob- Administration, 5100 Paint Branch tained from petroleum. It is refined to Pkwy., College Park, MD 20740, or meet the following specifications: available for inspection at the National (1) It meets the test requirements of Archives and Records Administration the United States Pharmacopeia XX (NARA). For information on the avail- (1980) for readily carbonizable sub- ability of this material at NARA, call stances (page 532). 202–741–6030, or go to: http:// (2) It meets the test requirements of www.archives.gov/federallregister/ U.S.P. XVII for sulfur compounds (page codeloflfederallregulations/ 400). (3) It meets the specifications pre- ibrllocations.html. scribed in the ‘‘Journal of the Associa- (b) White mineral oil may contain tion of Official Analytical Chemists,’’ any antioxidant permitted in food by Volume 45, page 66 (1962), which is in- regulations issued in accordance with corporated by reference, after correc- section 409 of the Act, in an amount tion of the ultraviolet absorbance for not greater than that required to any absorbance due to added anti- produce its intended effect. oxidants. Copies of the material incor- (c) White mineral oil is used or in- porated by reference are available from tended for use as follows:

Limitation (inclusive of all petroleum hydro- Use carbons that may be used in combination with white mineral oil)

1. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining concentrates of flavoring, spices, condiments, and nutrients intended for let. addition to food, excluding confectionery. 2. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab- taining food for special dietary use. let. 3. As a float on fermentation fluids in the manufacture of vinegar and wine to pre- In an amount not to exceed good manu- vent or retard access of air, evaporation, and wild yeast contamination during facturing practice. fermentation. 4. As a defoamer in food ...... In accordance with § 173.340 of this chapter. 5. In bakery products, as a release agent and lubricant ...... Not to exceed 0.15% of bakery products. 6. In dehydrated fruits and vegetables, as a release agent ...... Not to exceed 0.02% of dehydrated fruits and vegetables. 7. In egg white solids, as a release agent ...... Not to exceed 0.1% of egg white solids. 8. On raw fruits and vegetables, as a protective coating ...... In an amount not to exceed good manufacturing practice. 9. In frozen meat, as a component of hot-melt coating ...... Not to exceed 0.095% of meat. 10. As a protective float on brine used in the curing of pickles ...... In an amount not to exceed good manufacturing practice. 11. In molding starch used in the manufacture of confectionery ...... Not to exceed 0.3 percent in the molding starch. 12. As a release agent, binder, and lubricant in the manufacture of yeast ...... Not to exceed 0.15 percent of yeast. 13. As an antidusting agent in sorbic acid for food use ...... Not to exceed 0.25 percent in the sorbic acid. 14. As release agent and as sealing and polishing agent in the manufacture of Not to exceed 0.2 percent of confectionery. confectionery. 15. As a dust control agent for wheat, corn, soybean, barley, rice, rye, oats, and Applied at a level of no more than 0.02 sorghum. percent by weight of grain. 16. As a dust control agent for rice ...... ISO 100 oil viscosity (100 centistokes (cSt) at 100°F) applied at a level of no more than 0.08 percent by weight of the rice grain.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014, Dec. 1, 1998]

111

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00121 Fmt 8010 Sfmt 8016 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.880 21 CFR Ch. I (4–1–11 Edition)

§ 172.880 Petrolatum. subjected to the analytical procedure described in § 172.886(b): Petrolatum may be safely used in food, subject to the provisions of this Ultraviolet absorbance per centimeter section. path length: (a) Petrolatum complies with the Millimicrons Maximum specifications set forth in the United States Pharmacopeia XX (1980) for 280–289 ...... 0.25 290–299 ...... 20 white petrolatum or in the National 300–359 ...... 14 Formulary XV (1980) for petrolatum. 360–400 ...... 04 (b) Petrolatum meets the following ultraviolet absorbance limits when (c) Petrolatum is used or intended for use as follows:

Limitation (inclusive of all petroleum hydrocarbons Use that may be used in combination with petrolatum)

In bakery products; as release agent and lubricant ...... With white mineral oil, not to exceed 0.15 percent of bakery product. In confectionery; as release agent and as sealing and polishing agent ... Not to exceed 0.2 percent of confectionery. In dehydrated fruits and vegetables; as release agent ...... Not to exceed 0.02 percent of dehydrated fruits and vegetables. In egg white solids; as release agent ...... Not to exceed 0.1 percent of egg white solids. On raw fruits and vegetables; as protective coating ...... In an amount not to exceed good manufacturing practice. In beet sugar and yeast; as defoaming agent ...... As prescribed in § 173.340 of this chapter.

(d) Petrolatum may contain any 320–329 millimicrons—0.08 maximum. antioxidant permitted in food by regu- 330–350 millimicrons—0.05 maximum. lations issued in accordance with sec- Nonvolatile residual: 0.002 gram per 100 tion 409 of the Act, in an amount not milliliters maximum. greater than that required to produce Synthetic isoparaffinic petroleum hydro- its intended effect. carbons containing antioxidants shall meet the specified ultraviolet absorbance limits [42 FR 14491, Mar. 15, 1977, as amended at 49 after correction for any absorbance due to FR 10105, Mar. 19, 1984] the antioxidants. The ultraviolet absorbance shall be determined by the procedure de- § 172.882 Synthetic isoparaffinic petro- scribed for application of mineral oil, dis- leum hydrocarbons. regarding the last sentence of the procedure, under ‘‘Specifications’’ on page 66 of the Synthetic isoparaffinic petroleum ‘‘Journal of the Association of Official Ana- hydrocarbons may be safely used in lytical Chemists,’’ Volume 45 (February food, in accordance with the following 1962), which is incorporated by reference. conditions: Copies are available from the Center for (a) They are produced by synthesis Food Safety and Applied Nutrition (HFS– from petroleum gases and consist of a 200), Food and Drug Administration, 5100 mixture of liquid hydrocarbons meet- Paint Branch Pkwy., College Park, MD 20740, ing the following specifications: or available for inspection at the National Archives and Records Administration Boiling point 93–260 °C as determined by (NARA). For information on the availability ASTM method D86–82, ‘‘Standard Method for of this material at NARA, call 202–741–6030, Distillation of Petroleum Products,’’ which or go to: http://www.archives.gov/ is incorporated by reference. Copies may be federallregister/codeloflfederallregulations/ obtained from the American Society for ibrllocations.html. For hydrocarbons boiling Testing Materials, 100 Barr Harbor Dr., West below 250 °F, the nonvolatile residue shall be Conshohocken, Philadelphia, PA 19428-2959, determined by ASTM method D1353–78, or may be examined at the National Ar- ‘‘Standard Test Method for Nonvolatile Mat- chives and Records Administration (NARA). ter in Volatile Solvents for Use in Paint, For information on the availability of this Varnish, Lacquer, and Related Products;’’ material at NARA, call 202–741–6030, or go to: for those boiling above 121 °C, ASTM method http://www.archives.gov/federallregister/ D381–80, ‘‘Standard Test Method for Existent codeloflfederallregulations/ Gum in Fuels by Jet Evaporation’’ shall be ibrllocations.html. used. These methods are incorporated by ref- Ultraviolet absorbance: erence. Copies may be obtained from the 260–319 millimicrons—1.5 maximum. American Society for Testing Materials, 100

112

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00122 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.886

Barr Harbor Dr., West Conshohocken, Phila- § 178.3620(b)(1)(ii) of this chapter, as fol- delphia, PA 19428-2959, or may be examined lows: at the National Archives and Records Ad- ministration (NARA). For information on Maximum the availability of this material at NARA, absorb- call 202–741–6030, or go to: http:// μ ance per Wavelength m centimeter www.archives.gov/federallregister/ optical codeloflfederallregulations/ pathlength ibrllocations.html. 280–289 ...... 4.0 (b) Isoparaffinic petroleum hydro- 290–299 ...... 3.3 carbons may contain antioxidants au- 300–329 ...... 2.3 thorized for use in food in an amount 330–360 ...... 8 not to exceed that reasonably required to accomplish the intended technical (c) The additive is used as follows: effect nor to exceed any prescribed lim- Use Limitations itations. (c) Synthetic isoparaffinic petroleum As a coating on shell eggs ...... In an amount not to ex- hydrocarbons are used or intended for ceed good manufac- use as follows: turing practice. As a defoamer in processing beet Complying with sugar and yeast. § 173.340 of this chap- Uses Limitations ter. 1. In the froth-flotation cleaning of In an amount not to ex- As a float on fermentation fluids in In an amount not to ex- vegetables. ceed good manufac- the manufacture of vinegar and ceed good manufacturing practice. wine to prevent or retard ac- turing practice. 2. As a component of insecticide Do. cess of air, evaporation, and formulations for use on proc- wild yeast contamination during essed foods. fermentation. 3. As a component of coatings on Do. In the froth-flotation cleaning of Do. fruits and vegetables. vegetables. 4. As a coating on shell eggs ...... Do. As a component of insecticide for- Do. 5. As a float on fermentation Do. mulations used in compliance fluids in the manufacture of vin- with regulations issued in parts egar and wine and on brine 170 through 189 of this chapter. used in curing pickles, to prevent or retard access of air, evaporation, and contamination § 172.886 Petroleum wax. with wild organisms during fermentation. Petroleum wax may be safely used in or on food, in accordance with the fol- [42 FR 14491, Mar. 15, 1977, as amended at 47 lowing conditions: FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, (a) Petroleum wax is a mixture of 1984; 54 FR 24897, June 12, 1989] solid hydrocarbons, paraffinic in nature, derived from petroleum, and re- § 172.884 Odorless light petroleum hy- fined to meet the specifications pre- drocarbons. scribed by this section. Odorless light petroleum hydro- (b) Petroleum wax meets the fol- carbons may be safely used in food, in lowing ultraviolet absorbance limits accordance with the following pre- when subjected to the analytical proce- scribed conditions: dure described in this paragraph. (a) The additive is a mixture of liquid hydrocarbons derived from petroleum Maximum or synthesized from petroleum gases. ultraviolet absorb- The additive is chiefly paraffinic, ance per isoparaffinic, or naphthenic in nature. centimeter path length (b) The additive meets the following specifications: 280–289 millimicrons ...... 0.15 (1) Odor is faint and not kerosenic. 290–299 millimicrons ...... 0.12 (2) Initial boiling point is 300 °F min- 300–359 millimicrons ...... 0.08 imum. 360–400 millimicrons ...... 0.02 (3) Final boiling point is 650 °F maximum. (4) Ultraviolet absorbance limits determined by method specified in

113

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00123 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.886 21 CFR Ch. I (4–1–11 Edition)

ANALYTICAL SPECIFICATION FOR PETROLEUM Vigreaux vacuum-jacketed condenser (or WAX equivalent) about 45 centimeters in length and distilling head with separable cold finger GENERAL INSTRUCTIONS condenser. Use of tetrafluoroethylene poly- Because of the sensitivity of the test, the mer sleeves on the glass joints will prevent possibility of errors arising from contamina- freezing. Do not use grease on stopcocks or tion is great. It is of the greatest importance joints. that all glassware be scrupulously cleaned to Spectrophotometric cells. Fused quartz cells, remove all organic matter such as oil, optical path length in the range of 5.000 cen- ± grease, detergent residues, etc. Examine all timeters 0.005 centimeter; also for checking glassware, including stoppers and stopcocks, spectrophotometer performance only, optical under ultraviolet light to detect any residual path length in the range 1.000 centimeter ± fluorescent contamination. As a pre- 0.005 centimeter. With distilled water in the cautionary measure it is recommended prac- cells, determine any absorbance differences. tice to rinse all glassware with purified iso- Spectrophotometer. Spectral range 250 milli- octane immediately before use. No grease is microns–400 millimicrons with spectral slit to be used on stopcocks or joints. Great care width of 2 millimicrons or less, under instru- to avoid contamination of wax samples in ment operating conditions for these absorb- handling and to assure absence of any extra- ance measurements, the spectrophotometer neous material arising from inadequate shall also meet the following performance packaging is essential. Because some of the requirements: ± polynuclear hydrocarbons sought in this test Absorbance repeatability, 0.01 at 0.4 ab- are very susceptible to photo-oxidation, the sorbance. 1 ± entire procedure is to be carried out under Absorbance accuracy, 0.05 at 0.4 absorb- subdued light. ance. Wavelength repeatability, ±0.2 milli- APPARATUS micron. Wavelength accuracy, ±1.0 millimicron. Separatory funnels. 250–milliliter, 500–milli- Nitrogen cylinder. Water-pumped or equiva- liter, 1,000–milliliter, and preferably 2,000– lent purity nitrogen in cylinder equipped milliliter capacity, equipped with tetra- with regulator and valve to control flow at 5 fluoroethylene polymer stopcocks. p.s.i.g. Reservoir. 500–milliliter capacity, equipped with a 24/40 standard taper male fitting at REAGENTS AND MATERIALS the bottom and a suitable ball-joint at the Organic solvents. All solvents used through- top for connecting to the nitrogen supply. out the procedure shall meet the specifica- The male fitting should be equipped with tions and tests described in this specifica- glass hooks. tion. The isooctane, benzene, acetone, and Chromatographic tube. 180 millimeters in methyl alcohol designated in the list fol- length, inside diameter to be 15.7 millimeters lowing this paragraph shall pass the fol- ±0.1 millimeter, equipped with a coarse, frit- lowing test: ted-glass disc, a tetrafluoroethylene polymer To the specified quantity of solvent in a stopcock, and a female 24/40 standard tapered 250–milliliter Erlenmeyer flask, add 1 milli- fitting at the opposite end. (Overall length of liter of purified n-hexadecane and evaporate the column with the female joint is 235 million the steam bath under a stream of nitro- meters.) The female fitting should be gen (a) loose aluminum foil jacket around equipped with glass hooks. Disc. Tetrafluoroethylene polymer 2–inch 1 diameter disc approximately 3⁄16–inch thick As determined by using potassium chro- with a hole bored in the center to closely fit mate for reference standard and described in the stem of the chromatographic tube. National Bureau of Standards Circular 484, Heating jacket. Conical, for 500–milliliter Spectrophotometry, U.S. Department of separatory funnel. (Used with variable trans- Commerce, (1949). The accuracy is to be de- former heat control.) termined by comparison with the standard Suction flask. 250–milliliter or 500–milliliter values at 290, 345, and 400 millimicrons. Cir- filter flask. cular 484 is incorporated by reference. Copies Condenser. 24/40 joints, fitted with a drying are available from the Center for Food Safe- tube, length optional. ty and Applied Nutrition (HFS–200), Food Evaporation flask (optional). 250–milliliter and Drug Administration, 5100 Paint Branch or 500–milliliter capacity all-glass flask Pkwy., College Park, MD 20740, or available equipped with standard taper stopper having for inspection at the National Archives and inlet and outlet tubes to permit passage of Records Administration (NARA). For infor- nitrogen across the surface of contained liq- mation on the availability of this material uid to be evaporated. at NARA, call 202–741–6030, or go to: http:// Vacuum distillation assembly. All glass (for www.archives.gov/federallregister/ purification of dimethyl sulfoxide); 2–liter codeloflfederallregulations/ distillation flask with heating mantle; ibrllocations.html.

114

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00124 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.886

the flask will speed evaporation). Dis- milliliters of distilled water in a 500–milli- continue evaporation when not over 1 milliliter separatory funnel, mix and allow to liter of residue remains. (To the residue from cool for 5–10 minutes. Add 40 milliliters of benzene add a 10–milliliter portion of puri- isooctane to the solution and extract by fied isooctane, reevaporate, and repeat once shaking the funnel vigorously for 2 minutes. to insure complete removal of benzene.) Draw off the lower aqueous layer into a sec- Alternatively, the evaporation time can be ond 500–milliliter separatory funnel and re- reduced by using the optional evaporation peat the extraction with 40 milliliters of iso- flask. In this case the solvent and n-hexa- octane. Draw off and discard the aqueous decane are placed in the flask on the steam layer. Wash each of the 40–milliliter extrac- bath, the tube assembly is inserted, and a tives three times with 50–milliliter portions stream of nitrogen is fed through the inlet of distilled water. Shaking time for each tube while the outlet tube is connected to a wash is 1 minute. Discard the aqueous lay- solvent trap and vacuum line in such a way ers. Filter the first extractive through anhy- as to prevent any flow-back of condensate drous sodium sulfate prewashed with iso- into the flask. octane (see Sodium sulfate under ‘‘Reagents Dissolve the 1 milliliter of hexadecane res- and Materials’’ for preparation of filter), into idue in isooctane and make to 25 milliliters a 250–milliliter Erlenmeyer flask, or option- volume. Determine the absorbance in the 5– ally into the evaporating flask. Wash the centimeter path length cells compared to first separatory funnel with the second 40– isooctane as reference. The absorbance of the milliliter isooctane extractive, and pass solution of the solvent residue (except for through the sodium sulfate into the flask. methyl alcohol) shall not exceed 0.01 per cen- Then wash the second and first separatory timeter path length between 280 and 400 mμ. funnels successively with a 10–milliliter por- For methyl alcohol this absorbance value tion of isooctane, and pass the solvent shall be 0.00. through the sodium sulfate into the flask. Isooctane (2,2,4–trimethylpentane). Use 180 Add 1 milliliter of n-hexadecane and evapo- milliliters for the test described in the pre- rate the isooctane on the steam bath under ceding paragraph. Purify, if necessary, by nitrogen. Discontinue evaporation when not passage through a column of activated silica over 1 milliliter of residue remains. To the gel (Grade 12, Davison Chemical Company, residue, add a 10–milliliter portion of iso- Baltimore, Maryland, or equivalent) about 90 octane and reevaporate to 1 milliliter of centimeters in length and 5 centimeters to 8 hexadecane. Again, add 10 milliliters of iso- centimeters in diameter. octane to the residue and evaporate to 1 mil- Benzene, A.C.S. reagent grade. Use 150 milli- liliter of hexadecane to insure complete re- liters for the test. Purify, if necessary, by moval of all volatile materials. Dissolve the distillation or otherwise. 1 milliliter of hexadecane in isooctane and Acetone, A.C.S. reagent grade. Use 200 milli- make to 25–milliliter volume. Determine the liters for the test. Purify, if necessary, by reference. The absorbance of the solution distillation. should not exceed 0.02 per centimeter path Eluting mixtures: length in the 280 mμ–400 mμ range. (NOTE. 1. 10 percent benzene in isooctane. Pipet 50 Difficulty in meeting this absorbance speci- milliliters of benzene into a 500–milliliter fication may be due to organic impurities in glass-stoppered volumetric flask and adjust the distilled water. Repetition of the test to volume with isooctane, with mixing. omitting the dimethyl sulfoxide will disclose 2. 20 percent benzene in isooctane. Pipet 50 their presence. If necessary to meet the spec- milliliters of benzene into a 250–milliliter ification, purify the water by redistillation, glass-stoppered volumetric flask, and adjust passage through an ion-exchange resin, or to volume with isooctane, with mixing. otherwise.) 3. Acetone-benzene-water mixture. Add 20 Purify, if necessary, by the following pro- milliliters of water to 380 milliliters of ace- cedure: To 1,500 milliliters of dimethyl sulf- tone and 200 milliliters of benzene, and mix. oxide in a 2–liter glass-stoppered flask, add n-Hexadecane, 99 percent olefin-free. Dilute 6.0 milliliters of phosphoric acid and 50 1.0 milliliter of n-hexadecane to 25 milliliters grams of Norit A (decolorizing carbon, alka- with isooctane and determine the absorbance line) or equivalent. Stopper the flask, and in a 5–centimeter cell compared to isooctane with the use of a magnetic stirrer (tetra- as reference point between 280 mμ–400 mμ. fluoroethylene polymer coated bar) stir the The absorbance per centimeter path length solvent for 15 minutes. Filter the dimethyl shall not exceed 0.00 in this range. Purify, if sulfoxide through four thicknesses of fluted necessary, by percolation through activated paper (18.5 centimeters, Schleicher & silica gel or by distillation. Schuell, No. 597, or equivalent). If the initial Methyl alcohol, A.C.S. reagent grade. Use filtrate contains carbon fines, refilter 10.0 milliliters of methyl alcohol. Purify, if through the same filter until a clear filtrate necessary, by distillation. is obtained. Protect the sulfoxide from air Dimethyl sulfoxide. Pure grade, clear, and moisture during this operation by cov- water-white, m.p. 18° minimum. Dilute 120 ering the solvent in the funnel and collection milliliters of dimethyl sulfoxide with 240 flask with a layer of isooctane. Transfer the

115

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00125 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.886 21 CFR Ch. I (4–1–11 Edition)

filtrate to a 2–liter separatory funnel and per centimeter path length between 280 mμ draw off the dimethyl sulfoxide into the 2– and 400 mμ when tested as prescribed under liter distillation flask of the vacuum dis- ‘‘Organic solvents.’’ Usually three portions tillation assembly and distill at approxi- of wash solvent are sufficient. mately 3–millimeter Hg pressure or less. Dis- Before proceeding with analysis of a sam- card the first 200–milliliter fraction of the ple, determine the absorbance in a 5–centi- distillate and replace the distillate collec- meter path cell between 250 mμ and 400 mμ tion flask with a clean one. Continue the dis- for the reagent blank by carrying out the tillation until approximately 1 liter of the procedure, without a wax sample, at room sulfoxide has been collected. temperature, recording the spectra after the At completion of the distillation, the rea- extraction stage and after the complete pro- gent should be stored in glass-stoppered bot- cedure as prescribed. The absorbance per tles since it is very hygroscopic and will centimeter path length following the extrac- react with some metal containers in the tion stage should not exceed 0.040 in the presence of air. wavelength range from 280 mμ to 400 mμ; the Phosphoric acid. 85 percent A.C.S. reagent absorbance per centimeter path length fol- grade. lowing the complete procedure should not Sodium borohydride. 98 percent. exceed 0.070 in the wavelength range from 280 Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 299 mμ, inclusive, nor 0.045 in the ery Company, Westvaco Division, distributed by wavelength range from 300 mμ to 400 mμ. If in chemical supply firms, or equivalent). Place 100 either spectrum the characteristic benzene grams of the magnesium oxide in a large peaks in the 250 mμ–260 mμ region are beaker, add 700 milliliters of distilled water present, remove the benzene by the proce- to make a thin slurry, and heat on a steam dure under ‘‘Organic solvents’’ and record bath for 30 minutes with intermittent stir- absorbance again. ring. Stir well initially to insure that all the absorbent is completely wetted. Using a Place 300 milliliters of dimethyl sulfoxide Buchner funnel and a filter paper (Schleicher in a 1–liter separatory funnel and add 75 mil- & Schuell No. 597, or equivalent) of suitable liliters of phosphoric acid. Mix the contents diameter, filter with suction. Continue suc- of the funnel and allow to stand for 10 min- tion until water no longer drips from the utes. (The reaction between the sulfoxide funnel. Transfer the absorbent to a glass and the acid is exothermic. Release pressure trough lined with aluminum foil (free from after mixing, then keep funnel stoppered.) rolling oil). Break up the magnesia with a Add 150 milliliters of isooctane and shake to clean spatula and spread out the absorbent preequilibrate the solvents. Draw off the in- on the aluminum foil in a layer about 1 cen- dividual layers and store in glass-stoppered timeter to 2 centimeters thick. Dry for 24 flasks. hours at 160 °C ±1 °C. Pulverize the magnesia Place a representative 1–kilogram sample with mortar and pestle. Sieve the pulverized of wax, or if this amount is not available, the absorbent between 60–180 mesh. Use the mag- entire sample, in a beaker of a capacity nesia retained on the 180–mesh sieve. about three times the volume of the sample Celite 545. Johns-Manville Company, diato- and heat with occasional stirring on a steam maceous earth, or equivalent. bath until the wax is completely melted and Magnesium oxide-Celite 545 mixture (2+ 1) by homogeneous. Weigh four 25–gram ±0.2 gram weight. Place the magnesium oxide (60–180 portions of the melted wax in separate 100– mesh) and the Celite 545 in 2 to 1 propor- milliliter beakers. Reserve three of the portions, respectively, by weight in a glass- tions for later replicate analyses as nec- stoppered flask large enough for adequate essary. Pour one weighed portion imme- mixing. Shake vigorously for 10 minutes. diately after remelting (on the steam bath) Transfer the mixture to a glass trough lined into a 500–milliliter separatory funnel con- with aluminum foil (free from rolling oil) taining 100 milliliters of the preequilibrated and spread it out on a layer about 1 centi- sulfoxide-phosphoric acid mixture that has meter to 2 centimeters thick. Reheat the been heated in the heating jacket at a tem- mixture at 160 °C ±1 °C for 2 hours, and store perature just high enough to keep the wax in a tightly closed flask. melted. (NOTE: In preheating the sulfoxide- Sodium sulfate, anhydrous, A.C.S. reagent acid mixture, remove the stopper of the sepa- grade, preferably in granular form. For each ratory funnel at intervals to release the bottle of sodium sulfate reagent used, estab- pressure.) lish as follows the necessary sodium sulfate Promptly complete the transfer of the prewash to provide such filters required in sample to the funnel in the jacket with por- the method: Place approximately 35 grams of tions of the preequilibrated isooctane, warm- anhydrous sodium sulfate in a 30–milliliter ing the beaker, if necessary, and using a coarse, fritted-glass funnel or in a 65–milli- total volume of just 50 milliliters of the sol- meter filter funnel with glass wool plug; vent. If the wax comes out of solution during wash with successive 15–milliliter portions of these operations, let the stoppered funnel re- the indicated solvent until a 15–milliliter main in the jacket until the wax redissolves. portion of the wash shows 0.00 absorbance (Remove stopper from the funnel at intervals

116

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00126 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.886

to release pressure.) When the wax is in solu- to lose none of the solution in filling the tion, remove the funnel from the jacket and sample cell). Correct the absorbance values shake it vigorously for 2 minutes. Set up for any absorbance derived from reagents as three 250–milliliter separatory funnels with determined by carrying out the procedure each containing 30 milliliters of without a wax sample. If the corrected ab- preequilibrated isooctane. After separation sorbance does not exceed the limits pre- of the liquid phases, allow to cool until the scribed in this paragraph (b), the wax meets main portion of the wax-isooctane solution the ultraviolet absorbance specifications. If begins to show a precipitate. Gently swirl the corrected absorbance per centimeter the funnel when precipitation first occurs on path length exceeds the limits prescribed in the inside surface of the funnel to accelerate this paragraph (b), proceed as follows: this process. Carefully draw off the lower Quantitatively transfer the isooctane solu- layer, filter it slowly through a thin layer of tion to a 125–milliliter flask equipped with glass wool fitted loosely in a filter funnel 24/40 joint and evaporate the isooctane on into the first 250–milliliter separatory fun- the steam bath under a stream of nitrogen to nel, and wash in tandem with the 30–milli- a volume of 1 milliliter of hexadecane. Add liter portions of isooctane contained in the 10 milliliters of methyl alcohol and approxi- 250–milliliter separatory funnels. Shaking mately 0.3 gram of sodium borohydride. time for each wash is 1 minute. Repeat the (Minimize exposure of the borohydride to the extraction operation with two additional atmosphere. A measuring dipper may be portions of the sulfoxide-acid mixture, re- used.) Immediately fit a water-cooled con- placing the funnel in the jacket after each denser equipped with a 24/40 joint and with a extraction to keep the wax in solution and drying tube into the flask, mix until the washing each extractive in tandem through borohydride is dissolved, and allow to stand the same three portions of isooctane. for 30 minutes at room temperature, with Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe- liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the erably 2–liter), containing 480 milliliters of methyl alcohol on the steam bath under ni- distilled water, mix, and allow to cool for a trogen until the sodium borohydride begins few minutes after the last extractive has to come out of the solution. Then add 10 mil- been added. Add 80 milliliters of isooctane to liliters of isooctane and evaporate to a vol- the solution and extract by shaking the fun- ume of about 2–3 milliliters. Again, add 10 nel vigorously for 2 minutes. Draw off the milliliters of isooctane and concentrate to a lower aqueous layer into a second separatory volume of approximately 5 milliliters. Swirl funnel (preferably 2–liter) and repeat the ex- the flask repeatedly to assure adequate traction with 80 milliliters of isooctane. washing of the sodium borohydride residues. Draw off and discard the aqueous layer. Fit the tetrafluoroethylene polymer disc Wash each of the 80–milliliter extractives on the upper part of the stem of the three times with 100–milliliter portions of chromatographic tube, then place the tube distilled water. Shaking time for each wash with the disc on the suction flask and apply is 1 minute. Discard the aqueous layers. Fil- the vacuum (approximately 135 millimeters ter the first extractive through anhydrous Hg pressure). Weight out 14 grams of the 2:1 sodium sulfate prewashed with isooctane (see magnesium oxide-Celite 545 mixture and Sodium Sulfate under ‘‘Reagents and Mate- pour the adsorbent mixture into the rials’’ for preparation of filter) into a 250– chromatographic tube in approximately 3– milliliter Erlenmeyer flask (or optionally centimeter layers. After the addition of each into the evaporation flask). Wash the first layer, level off the top of the adsorbent with separatory funnel with the second 80–milli- a flat glass rod or metal plunger by pressing liter isooctane extractive and pass through down firmly until the adsorbent is well the sodium sulfate. Then wash the second packed. Loosen the topmost few millimeters and first separatory funnels successively of each adsorbent layer with the end of a with a 20–milliliter portion of isooctane and metal rod before the addition of the next pass the solvent through the sodium sulfate layer. Continue packing in this manner until into the flask. Add 1 milliliter of n-hexa- all the 14 grams of the adsorbent is added to decane and evaporate the isooctane on the the tube. Level off the top of the adsorbent steam bath under nitrogen. Discontinue by pressing down firmly with a flat glass rod evaporation when not over 1 milliliter of res- or metal plunger to make the depth of the idue remains. To the residue, add a 10–milli- adsorbent bed approximately 12.5 centi- liter portion of isooctane, reevaporate to 1 meters in depth. Turn off the vacuum and re- milliliter of hexadecane, and repeat this op- move the suction flask. Fit the 500–milliliter eration once. reservoir onto the top of the Quantitatively transfer the residue with chromatographic column and prewet the col- isooctane to a 25–milliliter volumetric flask, umn by passing 100 milliliters of isooctane make to volume, and mix. Determine the ab- through the column. Adjust the nitrogen sorbance of the solution in the 5–centimeter pressure so that the rate of descent of the path length cells compared to isooctane as isooctane coming off of the column is be- reference between 280 mμ–400 mμ (take care tween 2–3 milliliters per minute. Discontinue

117

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00127 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.886 21 CFR Ch. I (4–1–11 Edition)

pressure just before the last of the isooctane to volume in isooctane in a 25–milliliter vol- reaches the level of the adsorbent. (CAUTION: umetric flask. Record the absorbance again. Do not allow the liquid level to recede below If the corrected absorbance does not exceed the adsorbent level at any time.) Remove the the limits prescribed in this paragraph (b), reservoir and decant the 5–milliliter iso- the wax meets the ultraviolet absorbance octane concentrate solution onto the column specifications. and with slight pressure again allow the liquid level to recede to barely above the ad- (c) Petroleum wax may contain one sorbent level. Rapidly complete the transfer or more of the following adjuvants in similarly with two 5–milliliter portions of amounts not greater than that re- isooctane, swirling the flask repeatedly each quired to produce their intended effect: time to assure adequate washing of the res- (1) Antioxidants permitted in food by idue. Just before the final 5–milliliter wash regulations issued in accordance with reaches the top of the adsorbent, add 100 milliliters of isooctane to the reservoir and con- section 409 of the act. tinue the percolation at the 2–3 milliliter per (2) Poly(alkylacrylate) (CAS Reg. No. minute rate. Just before the last of the iso- 27029–57–8), made from long chain (C16- octane reaches the adsorbent level, add 100 C22) alcohols and acrylic acid, or milliliters of 10 percent benzene in isooctane poly(alkylmethacrylate) (CAS Reg. No. to the reservoir and continue the percolation 179529–36–3), made from long chain (C18- at the aforementioned rate. Just before the C ) methacrylate esters, having: solvent mixture reaches adsorbent level, add 22 25 milliliters of 20 percent benzene in iso- (i) A number average molecular octane to the reservoir and continue the per- weight between 40,000 and 100,000; colation at 2–3 milliliters per minute until (ii) A weight average molecular all this solvent mixture has been removed weight (MWw) to number average mo- from the column. Discard all the elution sol- lecular weight (MWn) ratio (MWw/MWn) vents collected up to this point. Add 300 mil- of not less than 3; and liliters of the acetone-benzene-water mixture to the reservoir and percolate through the (iii) Unreacted alkylacrylate or column to elute the polynuclear compounds. alkylmethacrylate monomer content Collect the eluate in a clean 1–liter sepa- not in excess of 14 percent, as deter- ratory funnel. Allow the column to drain mined by a method entitled ‘‘Method until most of the solvent mixture is re- for Determining Weight-Average and moved. Wash the eluate three times with Number-Average Molecular Weight and 300–milliliter portions of distilled water, for Determining Alkylacrylate Mon- shaking well for each wash. (The addition of small amounts of sodium chloride facilitates omer Content of Poly(alkylacrylate) separation.) Discard the aqueous layer after used as Processing Aid in Manufacture each wash. After the final separation, filter of Petroleum Wax,’’ which is incor- the residual benzene through anhydrous so- porated by reference in accordance dium sulfate prewashed with benzene (see So- with 5 U.S.C. 552(a) and 1 CFR part 51. dium sulfate under ‘‘Reagents and Materials’’ Copies are available from the Office of for preparation of filter) into a 250–milliliter Premarket Approval (HFS–200), Center Erlenmeyer flask (or optionally into the evaporation flask). Wash the separatory fun- for Food Safety and Applied Nutrition, nel with two additional 20–milliliter portions Food and Drug Administration, 5100 of benzene which are also filtered through Paint Branch Pkwy., College Park, MD the sodium sulfate. Add 1 milliliter of n- 20740, or may be examined at the Cen- hexadecane and completely remove the ben- ter for Food Safety and Applied Nutri- zene by evaporation under nitrogen, using tion’s Library, Food and Drug Admin- the special procedure to eliminate benzene istration, 5100 Paint Branch Pkwy., as previously described under ‘‘Organic Sol- College Park, MD 20740 or at the Na- vents.’’ Quantitatively transfer the residue with isooctane to a 25–milliliter volumetric tional Archives and Records Adminis- flask and adjust to volume. Determine the tration (NARA). For information on absorbance of the solution in the 5–centi- the availability of this material at meter path length cells compared to iso- NARA, call 202–741–6030, or go to: http:// octane as reference between 250 mμ–400 mμ. www.archives.gov/federallregister/ Correct for any absorbance derived from the codeloflfederallregulations/ reagents as determined by carrying out the ibrllocations.html. Petroleum wax shall procedure without a wax sample. If either contain not more than 1,050 parts per spectrum shows the characteristic benzene peaks in the 250 mμ–260 mμ region, evaporate million of poly(alkylacrylate) or the solution to remove benzene by the proce- poly(alkylmethacrylate) residues as dure under ‘‘Organic Solvents.’’ Dissolve the determined by a method entitled residue, transfer quantitatively, and adjust ‘‘Method for Determining Residual

118

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00128 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.892

Level of Poly(alkylacrylate) in Petro- Use Limitations leum Wax,’’ which is incorporated by On cheese and raw fruits and In an amount not to exceed reference. Copies are available from vegetables as a protective good manufacturing prac- the addresses cited in this paragraph. coating. tice. (d) Petroleum wax is used or intended As a defoamer in food ...... In accordance with § 173.340 for use as follows: of this chapter.

Use Limitations [42 FR 14491, Mar. 15, 1977, as amended at 59 In chewing gum base, as a mas- In an amount not to ex- FR 10986, Mar. 9, 1994] ticatory substance. ceed good manufacturing practice. § 172.890 Rice bran wax. On cheese and raw fruits and Do. vegetables as a protective coat- Rice bran wax may be safely used in ing. food in accordance with the following As a defoamer in food ...... In accordance with conditions: § 173.340 of this chap- (a) It is the refined wax obtained ter. As a component of microcapsules In accordance with from rice bran and meets the following for spice-flavoring substances. § 172.230 of this chap- specifications: ter. Melting point 75 °C to 80 °C. Free fatty acids, maximum 10 percent. [42 FR 14491, Mar. 15, 1977, as amended at 45 Iodine number, maximum 20. FR 48123, July 18, 1980; 47 FR 11838, Mar. 19, Saponification number 75 to 120. 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR (b) It is used or intended for use as 44122, Aug. 13, 1999] follows:

§ 172.888 Synthetic petroleum wax. Food Limitation in food Use

Synthetic petroleum wax may be Candy ...... 50 p.p.m ...... Coating. safely used in or on foods in accordance Fresh fruits and fresh ...... do ...... Do. with the following conditions: vegetables. Chewing gum ...... 21⁄2 pct ...... Plasticizing (a) Synthetic petroleum wax is a material. mixture of solid hydrocarbons, paraffinic in nature, prepared by either catalytic polymerization of ethylene or § 172.892 Food starch-modified. copolymerization of ethylene with lin- Food starch-modified as described in ear (C3 to C12) alpha-olefins, and refined this section may be safely used in food. to meet the specifications prescribed in The quantity of any substance em- this section. ployed to effect such modification shall (b) Synthetic petroleum wax meets not exceed the amount reasonably re- the ultraviolet absorbance limits of quired to accomplish the intended § 172.886(b) when subjected to the ana- physical or technical effect, nor exceed lytical procedure described therein. any limitation prescribed. To insure (c) Synthetic petroleum wax has a safe use of the food starch-modified, number average molecular weight of the label of the food additive container not less than 500 nor greater than 1,200 shall bear the name of the additive as determined by vapor pressure os- ‘‘food starch-modified’’ in addition to mometry. other information required by the Act. (d) Synthetic petroleum wax may Food starch may be modified by treat- contain any antioxidant permitted in ment prescribed as follows: food by regulations issued in accord- (a) Food starch may be acid-modified ance with section 409 of the act, in an by treatment with hydrochloric acid or amount not greater than that required sulfuric acid or both. to produce its intended effect. (b) Food starch may be bleached by (e) Synthetic petroleum wax is used treatment with one or more of the fol- or intended for use as follows: lowing:

Use Limitations Limitations

In chewing gum base, as a In accordance with § 172.615 Active oxygen obtained from hy- masticatory substance. in an amount not to exceed drogen peroxide and/or per- good manufacturing prac- acetic acid, not to exceed 0.45 tice. percent of active oxygen.

119

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00129 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 172.892 21 CFR Ch. I (4–1–11 Edition)

Limitations Limitations

Ammonium persulfate, not to ex- Vinyl acetate ...... Acetyl groups in food ceed 0.075 percent and sulfur starch-modified not to dioxide, not to exceed 0.05 per- exceed 2.5 percent. cent. Chlorine, as calcium hypochlorite, The finished food starch- (e) Food starch may be etherified by not to exceed 0.036 percent of modified is limited to dry starch. use only as a compo- treatment with one of the following: nent of batter for com- mercially processed Limitations foods. Chlorine, as sodium hypochlorite, Acrolein, not to exceed 0.6 per- not to exceed 0.0082 pound of cent. chlorine per pound of dry starch. Epichlorohydrin, not to exceed Potassium permanganate, not to Residual manganese 0.3 percent. exceed 0.2 percent. (calculated as Mn), not Epichlorohydrin, not to exceed Residual propylene to exceed 50 parts per 0.1 percent, and propylene chlorohydrin not more million in food starch- oxide, not to exceed 10 per- than 5 parts per million modified. cent, added in combination or in food starch-modified. Sodium chlorite, not to exceed 0.5 in any sequence. percent. Epichlorohydrin, not to exceed Do. 0.1 percent, followed by propylene oxide, not to exceed 25 (c) Food starch may be oxidized by percent. treatment with chlorine, as sodium hy- Propylene oxide, not to exceed Do. pochlorite, not to exceed 0.055 pound of 25 percent. chlorine per pound of dry starch. (d) Food starch may be esterified by (f) Food starch may be esterified and treatment with one of the following: etherified by treatment with one of the following: Limitations Limitations Acetic anhydride ...... Acetyl groups in food starch-modified not to Acrolein, not to exceed 0.6 per- Acetyl groups in food exceed 2.5 percent. cent and vinyl acetate, not to starch-modified not to Adipic anhydride, not to exceed Do. exceed 7.5 percent. exceed 2.5 percent. 0.12 percent, and acetic anhy- Epichlorohydrin, not to exceed 0.3 Acetyl groups in food dride. percent, and acetic anhydride. starch-modified not to Monosodium orthophosphate ...... Residual phosphate in exceed 2.5 percent. food starch-modified Epichlorohydrin, not to exceed 0.3 not to exceed 0.4 per- percent, and succinic anhy- cent calculated as dride, not to exceed 4 percent. phosphorus. Phosphorus oxychloride, not to Residual propylene 1–Octenyl succinic anhydride, not exceed 0.1 percent, and pro- chlorohydrin not more to exceed 3 percent. pylene oxide, not to exceed 10 than 5 parts per million 1–Octenyl succinic anhydride, not percent. in food starch-modi- to exceed 2 percent, and alu- fied. minum sulfate, not to exceed 2 percent. (g) Food starch may be modified by 1-Octenyl succinic anhydride, not Limited to use as a sta- treatment with one of the following: to exceed 3 percent, followed bilizer or emulsifier in by treatment with a beta-amy- beverages and bev- Limitations lase enzyme that is either an erage bases as de- approved food additive of is fined in § 170.3(n)(3) of Chlorine, as sodium hypochlorite, Residual propylene generally recognized as safe. this chapter. not to exceed 0.055 pound of chlorohydrin not more Phosphorus oxychloride, not to chlorine per pound of dry than 5 parts per million exceed 0.1 percent. starch; 0.45 percent of active in food starch-modi- Phosphorus oxychloride, not to Acetyl groups in food oxygen obtained from hydrogen fied. exceed 0.1 percent, followed by starch-modified not to peroxide; and propylene oxide, either acetic anhydride, not to exceed 2.5 percent. not to exceed 25 percent. exceed 8 percent, or vinyl ace- Sodium hydroxide, not to exceed tate, not to exceed 7.5 percent. 1 percent. Sodium trimetaphosphate ...... Residual phosphate in food starch-modified not to exceed 0.04 (h) Food starch may be modified by a percent, calculated as combination of the treatments pre- phosphorus. scribed by paragraphs (a), (b), and/or (i) Sodium tripolyphosphate and so- Residual phosphate in dium trimetaphosphate. food starch-modified of this section and any one of the not to exceed 0.4 per- treatments prescribed by paragraph (c), cent calculated as (d), (e), (f), or (g) of this section, sub- phosphorus. Succinic anhydride, not to exceed ject to any limitations prescribed by 4 percent. the paragraphs named.

120

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00130 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 172.898

(i) Food starch may be modified by mation required by the act, the name treatment with the following enzymes: of the additive as follows: (1) The additive identified in para- Enzyme Limitations graph (a)(1) of this section as ‘‘par- Alpha-amylase (E.C. 3.2.1.1) ...... The enzyme must be tially defatted, cooked cottonseed generally recognized flour’’. as safe or approved as (2) The additive identified in para- a food additive for this purpose. The resulting graph (a)(2) of this section as ‘‘defatted nonsweet nutritive sac- cottonseed flour’’. charide polymer has a (3) The additive identified in para- dextrose equivalent of less than 20. graph (a)(3) of this section as ‘‘roasted Beta-amylase (E.C. 3.2.1.2). glandless cottonseed kernels’’. Glucoamylase (E.C. 3.2.1.3). (4) The additive identified in para- Isoamylase (E.C. 3.2.1.68). graph (a)(4) of this section as ‘‘raw Pullulanase (E.C. 3.2.1.41). glandless cottonseed kernels for use in cooked hard candy’’. [42 FR 14491, Mar. 15, 1977, as amended at 43 (d) The Food and Drug Administra- FR 11697, Mar. 21, 1978; 46 FR 32015, June 19, 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, tion and the Environmental Protection Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001] Agency have determined that glandless cottonseed kernels permitted for use § 172.894 Modified cottonseed products by this section are a distinct com- intended for human consumption. modity from glanded cottonseed. The food additive modified cottonseed products may be used for human § 172.896 Dried yeasts. consumption in accordance with the Dried yeast (Saccharomyces cerevisiae following prescribed conditions: and Saccharomyces fragilis) and dried (a) The additive is derived from: torula yeast (Candida utilis) may be (1) Decorticated, partially defatted, safely used in food provided the total cooked, ground cottonseed kernels; or folic acid content of the yeast does not (2) Decorticated, ground cottonseed exceed 0.04 milligram per gram of yeast kernels, in a process that utilizes n- (approximately 0.008 milligram of hexane as an extracting solvent in such pteroyglutamic acid per gram of a way that no more than 60 parts per yeast). million of n-hexane residues and less than 1 percent fat by weight remain in § 172.898 Bakers yeast glycan. the finished product; or Bakers yeast glycan may be safely (3) Glandless cottonseed kernels used in food in accordance with the fol- roasted to attain a temperature of not lowing conditions: less than 250 °F in the kernel for not (a) Bakers yeast glycan is the less than 5 minutes for use as a snack comminuted, washed, pasteurized, and food, or in baked goods, or in soft dried cell walls of the yeast, Saccharo- candy; or myces cerevisiae. It is composed prin- (4) Raw glandless cottonseed kernels cipally of long chain carbohydrates, may be used in hard candy where the not less than 85 percent on a dry solids kernel temperature during cooking basis. The carbohydrate is composed of will exceed 250 °F for not less than 5 glycan and mannan units in approxi- minutes. mately a 2:1 ratio. (b) The additive is prepared to meet (b) The additive meets the following the following specifications: specifications on a dry weight basis: (1) Free gossypol content not to ex- Less than 0.4 part per million (ppm) ar- ceed 450 parts per million. senic, 0.13 ppm cadmium, 0.2 ppm lead, (2) It contains no added arsenic com- 0.05 ppm mercury, 0.09 ppm selenium, pound and therefore may not exceed a and 10 ppm zinc. maximum natural background level of (c) The viable microbial content of 0.2 part per million total arsenic, cal- the finished ingredient is: culated as As. (1) Less than 10,000 organisms/gram (c) To assure safe use of the additive, by aerobic plate count. the label of the food additive container (2) Less than 10 yeasts and molds/ shall bear, in addition to other infor- gram.

121

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00131 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Pt. 173 21 CFR Ch. I (4–1–11 Edition)

(3) Negative for Salmonella, E. coli, 173.45 Polymaleic acid and its sodium salt. coagulase positive Staphylococci, Clos- 173.50 Polyvinylpolypyrrolidone. tridium perfringens, Clostridium botu- 173.55 Polyvinylpyrrolidone. linum, or any other recognized micro- 173.60 Dimethylamine-epichlorohydrin copolymer. bial pathogen or any harmful microbial 173.65 Divinylbenzene copolymer. toxin. 173.70 Chloromethylated aminated styrene- (d) The additive is used or intended divinylbenzene resin. for use in the following foods when 173.73 Sodium polyacrylate. standards of identity established under 173.75 Sorbitan monooleate. section 401 of the Act do not preclude such use: Subpart B—Enzyme Preparations and Microorganisms Use Limitations 173.110 Amyloglucosidase derived from (1) In salad dressings as an emul- Not to exceed a con- Rhizopus niveus. sifier and emulsifier salt as de- centration of 5 percent 173.115 Alpha-acetolactate decarboxylase (a- fined in § 170.3(o)(8) of this of the finished salad ALDC) enzyme preparation derived from chapter, stabilizer and thickener dressing. a recombinant Bacillus subtilis. as defined in § 170.3(o)(28) of this chapter, or texturizer as de- 173.120 Carbohydrase and cellulase derived fined in § 170.3(o)(32) of this from Aspergillus niger. chapter. 173.130 Carbohydrase derived from Rhizopus (2) In frozen dessert analogs as a In an amount not to ex- oryzae. stabilizer and thickener as de- ceed good manufac- 173.135 Catalase derived from Microccocus fined in § 170.3(o)(28) of this turing practice. lysodeikticus. chapter, or texturizer as defined 173.140 Esterase-lipase derived from Mucor in § 170.3(o)(32) of this chapter. (3) In sour cream analogs as a Do. miehei. stabilizer and thickener as de- 173.145 Alpha-Galactosidase derived from fined in § 170.3(o)(28) of this Mortierella vinaceae var. raffinoseutilizer. chapter, or texturizer as defined 173.150 Milk-clotting enzymes, microbial. in § 170.3(o)(32) of this chapter. 173.160 Candida guilliermondii. (4) In cheese spread analogs as Do. 173.165 Candida lipolytica. a stabilizer and thickener as de- ′ fined in § 170.3(o)(28) of this 173.170 Aminoglycoside 3 -phosphotrans- chapter, or texturizer as defined ferase II. in § 170.3(o)(32) of this chapter. (5) In cheese-flavored and sour Do. Subpart C—Solvents, Lubricants, Release cream-flavored snack dips as a Agents and Related Substances stabilizer and thickener as defined in § 170.3(o)(28) of this 173.210 Acetone. chapter, or texturizer as defined 173.220 1,3–Butylene glycol. in § 170.3(o)(32) of this chapter. 173.228 Ethyl acetate. 173.230 Ethylene dichloride. (e) The label and labeling of the in- 173.240 Isopropyl alcohol. gredient shall bear adequate directions 173.250 Methyl alcohol residues. to assure that use of the ingredient 173.255 Methylene chloride. complies with this regulation. 173.270 Hexane. 173.275 Hydrogenated sperm oil. [42 FR 14491, Mar. 15, 1977, as amended at 45 173.280 Solvent extraction process for citric FR 58836, Sept. 5, 1980] acid. 173.290 Trichloroethylene. PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN Subpart D—Specific Usage Additives FOOD FOR HUMAN CONSUMP- 173.300 Chlorine dioxide. TION 173.310 Boiler water additives. 173.315 Chemicals used in washing or to as- Subpart A—Polymer Substances and sist in the peeling of fruits and vegeta- Polymer Adjuvants for Food Treatment bles. 173.320 Chemicals for controlling micro- Sec. organisms in cane-sugar and beet-sugar 173.5 Acrylate-acrylamide resins. mills. 173.10 Modified polyacrylamide resin. 173.322 Chemicals used in delinting cotton- 173.20 Ion-exchange membranes. seed. 173.21 Perfluorinated ion exchange mem- 173.325 Acidified sodium chlorite solutions. branes. 173.340 Defoaming agents. 173.25 Ion-exchange resins. 173.342 Chlorofluorocarbon 113 and 173.40 Molecular sieve resins. perfluorohexane.

122

VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00132 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR